Method of fusing a sacroiliac joint with an implant with voids

ABSTRACT

A method for fixating a dysfunctional sacroiliac joint for SI joint fusion including implanting a joint implant at the sacroiliac joint. The joint implant may include a body extending a length between a proximal end and a distal end, an exterior surface, an interior surface opposite the exterior surface and defining an internal volume therein, a wall thickness extending between the exterior surface and the interior surface, a proximal opening extending into the internal volume, and a first plurality of voids along the length and extending through the wall thickness from the exterior surface to the interior surface. The first plurality of voids may be arranged along the length in a repeating pattern of a group of voids, wherein each void of the first plurality of voids is generally polygonal in shape.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.15/910,753 filed Mar. 2, 2018, which application is a continuation ofU.S. application Ser. No. 15/828,677 filed Dec. 1, 2017, now U.S. Pat.No. 9,931,212, which application is a continuation of U.S. applicationSer. No. 15/061,524 filed Mar. 4, 2016, now U.S. Pat. No. 9,833,320,which application is a divisional of U.S. application Ser. No.13/946,790 filed Jul. 19, 2013, now U.S. Pat. No. 9,333,090, whichapplication claims priority to and incorporates by reference in itsentirety U.S. Provisional Patent Application Nos.; 61/674,277, filedJul. 20, 2012; 61/800,120, filed Mar. 15, 2013; and 61/674,130, filedJul. 20, 2012.

Application Ser. No. 13/946,790 is also a continuation-in-part (CIP)application of U.S. patent application Ser. No. 13/475,695 (“the '695application”), which was filed May 18, 2012, now U.S. Pat. No.9,381,045. The '695 application is a continuation-in-part (CIP)application of and claims priority to U.S. patent application Ser. No.13/236,411 (“the '411 application), which is entitled “Systems for andMethods of Fusing a Sacroiliac Joint” and was filed Sep. 19, 2011, nowU.S. Pat. No. 9,017,407.

The '411 application is a continuation-in-part (CIP) application of andclaims priority to U.S. patent application Ser. No. 12/998,712 (“the'712 application”), which was filed May 23, 2011, now U.S. Pat. No.8,979,928. The '712 application is the National Stage of InternationalPatent Cooperation Treaty Patent Application PCT/US2011/000070 (the “PCTapplication”), which was filed Jan. 13, 2011. The PCT application claimspriority to U.S. Provisional Patent Application 61/335,947, which wasfiled Jan. 13, 2010.

All of the aforementioned applications are hereby incorporated byreference in their entireties into the present application.

The delivery approaches and methodologies disclosed in the above-listedapplications and incorporated herein are applicable to the implants anddelivery tools disclosed in the present application.

FIELD OF THE INVENTION

Aspects of the present invention relate to medical apparatus andmethods. More specifically, the present invention relates to devices andmethods for fusing a sacroiliac joint.

BACKGROUND OF THE INVENTION

The sacroiliac joint is the joint between the sacrum and the ilium ofthe pelvis, which are joined by ligaments. In humans, the sacrumsupports the spine and is supported in turn by an ilium on each side.The sacroiliac joint is a synovial joint with articular cartilage andirregular elevations and depressions that produce interlocking of thetwo bones.

Pain associated with the sacroiliac joint can be caused by traumaticfracture dislocation of the pelvis, degenerative arthritis, sacroiliitisan inflammation or degenerative condition of the sacroiliac joint,osteitis condensans ilii, or other degenerative conditions of thesacroiliac joint. Currently, sacroiliac joint fusion is most commonlyadvocated as a surgical treatment for these conditions. Fusion of thesacroiliac joint can be accomplished by several different conventionalmethods encompassing an anterior approach, a posterior approach, and alateral approach with or without percutaneous screw or other typeimplant fixation. However, while each of these methods has been utilizedfor fixation and fusion of the sacroiliac joint over the past severaldecades, substantial problems with respect to the fixation and fusion ofthe sacroiliac joint remain unresolved.

A significant problem with certain conventional methods for fixation andfusion of the sacroiliac joint including the anterior approach,posterior approach, or lateral approach may be that the surgeon has tomake a substantial incision in the skin and tissues for direct access tothe sacroiliac joint involved. These invasive approaches allow thesacroiliac joint to be seen and touched directly by the surgeon. Oftenreferred to as an “open surgery”, these procedures have the attendantdisadvantages of requiring general anesthesia and can involve increasedoperative time, hospitalization, pain, and recovery time due to theextensive soft tissue damage resulting from the open surgery.

A danger to open surgery using the anterior approach can be damage tothe L5 nerve root, which lies approximately two centimeters medial tothe sacroiliac joint or damage to the major blood vessels. Additionally,these procedures typically involve fixation of the sacroiliac joint(immobilization of the articular surfaces of the sacroiliac joint inrelation to one another) by placement of one or more screws or one ormore trans-sacroiliac implants (as shown by the non-limiting example ofFIG. 1) or by placement of implants into the S1 pedicle and iliac bone.

Use of trans-sacroiliac and S1 pedicle-iliac bone implants can alsoinvolve the risk of damage to the lumbosacral neurovascular elements.Damage to the lumbosacral neurovascular elements as well as delayedunion or non-union of the sacroiliac joint by use of these proceduresmay require revision surgery to remove all or a portion of the implantsor repeat surgery as to these complications.

Another significant problem with conventional procedures utilizingminimally invasive small opening procedures can be that the proceduresare technically difficult, requiring biplanar fluoroscopy of thearticular surfaces of the sacroiliac joint and extensive surgicaltraining and experience. Despite the level of surgical training andexperience, there is a substantial incidence of damage to thelumbosacral neurovascular elements. Additionally, sacral anomalies canfurther lead to mal-placement of implants leading to damage ofsurrounding structures. Additionally, these procedures are oftenperformed without fusion of the sacroiliac joint, which does not removethe degenerative joint surface and thereby does not address thedegenerative condition of the sacroiliac joint, which may lead tocontinued or recurrent sacroiliac joint pain.

Another significant problem with conventional procedures can be theutilization of multiple trans-sacroiliac elongate implants, which do notinclude a threaded surface. This approach requires the creation oftrans-sacroiliac bores in the pelvis and nearby sacral foramen, whichcan be of relatively large dimension and which are subsequently broachedwith instruments, which can result in bone being impacted into thepelvis and neuroforamen.

The creation of the trans-sacroiliac bores and subsequent broaching ofthe bores requires a guide pin, which may be inadvertently advanced intothe pelvis or sacral foramen, resulting in damage to other structures.Additionally, producing the trans-sacroiliac bores, broaching, orplacement of the elongate implants may result in damage to thelumbosacral neurovascular elements, as above discussed. Additionally,there may be no actual fusion of the articular portion of the sacroiliacjoint, which may result in continued or recurrent pain requiringadditional surgery.

Another substantial problem with conventional procedures can be thatplacement of posterior extra-articular distracting fusion implants andbone grafts may be inadequate with respect to removal of the articularsurface or preparation of cortical bone, the implant structure andfixation of the sacroiliac joint. The conventional procedures may notremove sufficient amounts of the articular surfaces or cortical surfacesof the sacroiliac joint to relieve pain in the sacroiliac joint. Theconventional implant structures may have insufficient or avoidengagement with the articular surfaces or cortical bone of thesacroiliac joint for adequate fixation or fusion. The failure tosufficiently stabilize and fuse the sacroiliac joint with theconventional implant structures and methods may result in a failure torelieve the condition of sacroiliac joint being treated. Additionally,conventional methods of driving apart a sacrum and ilium may lead tomal-alignment of the sacroiliac joint and increased pain.

The inventive sacroiliac fusion system described herein addresses theproblems associated with conventional methods and apparatuses used infixation and fusion of the sacroiliac joint.

BRIEF SUMMARY OF THE INVENTION

One implementation of the present disclosure may take the form of asacroiliac joint fusion system including a joint implant, an anchorelement and a delivery tool. The joint implant includes a distal end, aproximal end, a body extending between the proximal and distal ends, anda first bore extending non-parallel to a longitudinal axis of the body.The anchor element includes a distal end and a proximal end and isconfigured to be received in the first bore. The delivery tool includesan implant arm and an anchor arm. The implant arm includes a proximalend and a distal end. The distal end of the implant arm is configured toreleasably couple to the proximal end of the joint implant such that alongitudinal axis of the implant arm is substantially at least one ofcoaxial or parallel with the longitudinal axis of the body of the jointimplant. The anchor arm includes a proximal end and a distal end. Thedistal end of the anchor arm is configured to engage the proximal end ofthe anchor element. The anchor arm is operably coupled to the implantarm in an arrangement such that the longitudinal axis of the anchorelement is generally coaxially aligned with a longitudinal axis of thefirst bore when the distal end of the implant arm is releasably coupledwith the proximal end of the joint implant and the distal end of theanchor arm is engaged with the proximal end of the anchor element. Thearrangement is fixed and nonadjustable.

Another implementation of the present disclosure may take the form of asacroiliac joint fusion system including a joint implant, an anchorelement and a delivery tool. The joint implant includes a distal end, aproximal end, a body extending between the proximal and distal ends, anda first bore extending non-parallel to a longitudinal axis of the body.The anchor element includes a distal end and a proximal end and isconfigured to be received in the first bore. The delivery tool includesan implant arm and an anchor arm. The implant arm includes a proximalend and a distal end. The distal end of the implant arm is configured toreleasably couple to the proximal end of the joint implant such that alongitudinal axis of the implant arm is substantially at least one ofcoaxial or parallel with the longitudinal axis of the body of the jointimplant. The anchor arm includes a proximal end and a distal end. Thedistal end of the anchor arm includes a guide. The anchor arm ispivotally coupled to the implant arm and configured such that a centerof the guide moves along an arc that extends through generally thecenter of the first bore of the implant when the distal end of theimplant arm is releasably coupled with the proximal end of the jointimplant. The anchor arm is configured to deliver the anchor element tothe first bore.

Yet another implementation of the present disclosure may take the formof a sacroiliac joint fusion system including a joint implant and atool. In one embodiment, the joint implant includes a longitudinal axisand a first bore extending non-parallel to the longitudinal axis. Theanchor element is configured to be received in the first bore. Thedelivery tool includes an implant arm and an anchor arm. The implant armis configured to releasably couple to the joint implant. The anchor armis coupled to the implant arm and configured to deliver the anchorelement to the first bore. The final manufactured configuration of thetool and final manufactured configuration of the joint implant are suchthat, when the system is assembled such that the implant arm isreleasably coupled to the joint implant, a delivery arrangementautomatically exists such that the anchor arm is correctly oriented todeliver the anchor element to the first bore.

Another implementation of the present disclosure may take the form of amethod of sacroiliac joint fusion. In one embodiment, the methodincludes: a) approaching a sacroiliac joint space with a joint implantcomprising at least first and second planar members radially extendinggenerally coplanar with each other from opposite sides of a body of thejoint implant; b) delivering the joint implant into a sacroiliac jointspace, the joint implant being oriented in the sacroiliac joint spacesuch that the first and second planar members are generally coplanarwith a joint plane of the sacroiliac joint space; and c) causing ananchor element to be driven generally transverse to the joint planethrough bone material defining at least a portion of the sacroiliacjoint space and into a bore of the joint implant that extends generallytransverse to the body of the joint implant.

Yet another implementation of the present disclosure may take the formof a medical kit for the fusion of a sacroiliac joint including a caudalaccess region and a joint plane. In one embodiment, the kit includes: a)a delivery tool comprising an implant arm and an anchor arm coupled tothe implant arm; b) a joint implant comprising a bore defined thereinthat extends generally transverse to a longitudinal length of the jointimplant; and c) an anchor element configured to be received in the boreof the joint implant. The bore of the implant, the implant, the implantarm and the anchor arm have an as-manufactured configuration that allowsthe anchor arm to properly align the anchor element to be received inthe bore of the implant when the implant is coupled to the implant arm.

One implementation of the present disclosure may take the form ofvarious embodiments of a sacroiliac joint fusion system including jointimplants and delivery tools.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present disclosure.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an anterior view of the pelvic region and a conventionalmethod and device for stabilizing the sacroiliac joint.

FIG. 2A is an isometric view of a first embodiment of a system forfusing a sacroiliac joint.

FIG. 2B is the same view as FIG. 2A, except the delivery tool andimplant assembly are decoupled from each other.

FIG. 3 is the same view as FIG. 2A, except the system is exploded tobetter illustrate its components.

FIG. 4 is a top-side isometric view of the implant assembly.

FIG. 5 is a distal end isometric view of the implant of the implantassembly of FIG. 4.

FIG. 6 is a proximal end isometric view of the implant.

FIG. 7 is a bottom-side isometric view of the implant assembly.

FIG. 8 is another proximal end isometric view of the implant.

FIG. 9 is another distal end isometric view of the implant.

FIGS. 10 and 11 are opposite side elevation views of the implant.

FIGS. 12 and 13 are opposite plan views of the implant.

FIG. 14 is a distal end elevation of the implant.

FIG. 15 is a proximal end elevation of the implant.

FIG. 16 is an isometric longitudinal cross section of the implant astaken along section line 16-16 of FIG. 11.

FIG. 17 is an isometric longitudinal cross section of the implant astaken along section line 17-17 of FIG. 13.

FIG. 18 is a proximal isometric view of the arm assembly.

FIG. 19 is a distal isometric view of the arm assembly 85.

FIG. 20 is a longitudinal cross section of the implant arm as takenalong section line 20-20 in FIG. 18.

FIG. 21A is a side elevation of the system wherein the tool is attachedto the implant assembly for delivery of the implant assembly to thesacroiliac joint.

FIG. 21B is the same view as FIG. 21A, except illustrating a series ofinterchangeable anchor arms that may be coupled to the implant arm toadjust the tool for the patient, but maintain the angular relationshipbetween the components of system that allows the anchor member to bedelivered into the implant bore without adjustment to the delivery tool.

FIG. 21C is the same view of FIG. 21A, except illustrating a version ofthe same embodiment wherein the anchor arm is more proximally locatedalong the implant arm.

FIG. 22 is the same view as FIG. 21A, except shown as a longitudinalcross section.

FIG. 23 is an enlarged view of the distal region of the system circledin FIG. 22.

FIG. 24 is an enlarged cross sectional plan view taken in a plane 90degrees from the section plane of FIG. 23.

FIG. 25 is a proximal isometric view of the handle.

FIG. 26 is a distal isometric view of the handle.

FIG. 27 is a cross sectional distal isometric view of the handle.

FIG. 28 is an isometric view of the implant retainer.

FIG. 29 is a longitudinal cross sectional isometric view of the implantretainer.

FIG. 30A is an isometric view of the sleeve.

FIG. 30B is a longitudinal cross section of an embodiment of the sleevehaving multiple sleeve portions.

FIG. 31 is an isometric view of a trocar, guidewire, drill, screwdriver,etc. for insertion through the lumen of the sleeve.

FIG. 32 is an isometric view of a second embodiment of a system forfusing a sacroiliac joint.

FIG. 33 is the same view as FIG. 32, except the system is exploded tobetter illustrate its components.

FIG. 34 is a side elevation of the system embodiment of FIG. 32.

As shown in FIG. 35 is a proximal isometric view of the implant arm ofthe embodiment of FIG. 32.

FIG. 36 is an isometric view of the anchor arm.

FIGS. 37 and 38 are different isometric views of a third embodiment ofthe system.

FIG. 39 is the same view as FIG. 37, except the system is shown explodedto better illustrate the components of the system.

FIG. 40 is a side elevation of the system of FIG. 37, wherein the toolis attached to the implant assembly for delivery of the implant assemblyto the sacroiliac joint.

FIGS. 41-44 are various isometric views of the implant of the thirdembodiment of the system.

FIGS. 45-46 are opposite plan views of the implant.

FIGS. 47-50 are various elevation views of the implant.

FIGS. 51-52 are, respectively, isometric and side elevation views of animplant having an anchor member receiving arm.

FIG. 53 is an enlarged view of the disk-shaped seat of the implant armof FIG. 51.

FIG. 54 is an isometric view of an implant with another type of anchormember locking mechanism.

FIG. 55 is an enlarged view of the free end of the anchor member lockingmechanism of FIG. 54.

FIGS. 56-61 are, respectively, front isometric, rear isometric, sideelevation, plan, front elevation, and rear elevation views of anotherembodiment of the implant.

FIGS. 62-67 are, respectively, front isometric, rear isometric, sideelevation, plan, front elevation, and rear elevation views of yetanother embodiment of the implant.

FIGS. 68-73 are, respectively, front isometric, rear isometric, sideelevation, plan, front elevation, and rear elevation views of stillanother embodiment of the implant.

FIGS. 74-79 are, respectively, front isometric, rear isometric, sideelevation, plan, front elevation, and rear elevation views of yetanother embodiment of the implant.

FIGS. 80-85 are, respectively, front isometric, rear isometric, sideelevation, plan, front elevation, and rear elevation views of still yetanother embodiment of the implant.

FIG. 86 is an isometric view of the delivery tool.

FIGS. 87-88 are generally opposite isometric views of the delivery toolin an exploded state.

FIG. 89 is an isometric view of the handle.

FIG. 90 is an exploded isometric view of the retaining collar and handleshown in longitudinal cross section.

FIG. 91 is a longitudinal cross section of the delivery tool 20 whenassembled as shown in FIG. 86.

FIG. 92 is a side view of an implant retainer similar to that describedwith respect to FIGS. 86-91, except having a modified distal end.

FIGS. 93-94 are, respectively, longitudinal and transverse crosssectional views of an implant with an engagement hole configured tocomplementarily engage with the T-shaped distal end of the retainer ofFIG. 92.

FIG. 95 is the same view as FIG. 93, except with the retainer receivedin the hole.

FIG. 96A is a right lateral side view of a hip region of a patient lyingprone, wherein the soft tissue surrounding the skeletal structure of thepatient is shown in dashed lines.

FIG. 96B is an enlarged view of the hip region of FIG. 96A.

FIG. 97A is a lateral-posterior view of the hip region of the patient ofFIG. 96A, wherein the patient is lying prone and the soft tissuesurrounding the skeletal structure of the patient is shown in dashedlines.

FIG. 97B is an enlarged view of the hip region of FIG. 97A.

FIG. 98A is a posterior view of the hip region of the patient of FIG.96A, wherein the patient is lying prone and the soft tissue surroundingthe skeletal structure of the patient is shown in dashed lines.

FIG. 98B is an enlarged view of the hip region of FIG. 98A.

FIGS. 99A-99Q are each a step in the methodology and illustrated as thesame transverse cross section taken along a plane extendingmedial-lateral and anterior posterior along section line 99-99 in FIG.98B.

FIG. 100A is a posterior-lateral view of the hip region of the patient,illustrating the placement of a cannula alignment jig.

FIGS. 100B-100C are different isometric views of the cannula alignmentjig.

FIG. 101A is a posterior-lateral view of the hip region of the patient,illustrating the placement of a drill jig.

FIG. 101B is an isometric view of the drill jig.

FIG. 102A is a lateral view of the hip region of the patient,illustrating the implant implanted in the caudal region of thesacroiliac joint space.

FIG. 102B is an anterior view of the hip region of the patient,illustrating the implant implanted in the caudal region of thesacroiliac joint space.

FIG. 102C is an enlarged view of the implant taken along the plane ofthe sacroiliac joint.

FIG. 102D is a transverse cross section of the implant and joint planetaken along section line 102D-102D of FIG. 102C.

FIG. 103A is generally the same view as FIG. 97A, except illustratingthe delivery tool being used to deliver the implant to the sacroiliacjoint space.

FIG. 103B is an enlarged view of the hip region of FIG. 103A.

FIG. 104 is generally the same enlarged view as FIG. 96B, exceptillustrating the delivery tool being used to deliver the implant to thesacroiliac joint space.

FIG. 105 is the same view as FIG. 104, except the implant has now beenfully inserted into the prepared space in the sacroiliac joint.

FIG. 106A is the same view as FIG. 104, except the sleeve is nowreceived in the collar of the anchor arm.

FIG. 106B is generally the same view as FIG. 106A, except the ilium isremoved to show the sacroiliac joint space boundary defined along thesacrum and the implant positioned for implantation within the jointspace.

FIG. 107A is a posterior-inferior view of the hip region of the patient,wherein the soft tissue surrounding the skeletal hip bones is shown indashed lines.

FIG. 107B is an enlarged view of the implant region of FIG. 107A.

FIGS. 108A and 108B are, respectively, posterior and posterior-lateralviews of the implantation area and the implant assembly implanted there.

FIG. 109 is an isometric view of the system wherein the tool is attachedto the implant for delivery of the implant to the sacroiliac joint.

FIG. 110 is a view of the system wherein the implant and anchor arm areshown in plan view.

FIG. 111A is an inferior-posterior view of the patient's hip skeletalstructure similar to the view depicted in FIG. 107A.

FIG. 111B is a lateral-superior-posterior view of the patient's hipskeletal structure.

FIG. 111C is an inferior-posterior view of the patient's hip skeletalstructure taken from a perspective laterally opposite the view depictedin FIG. 111B.

FIG. 112A is an inferior-posterior view of the patient's hip skeletalstructure similar to the view depicted in FIG. 107A.

FIG. 112B is a side view of the patient's hip skeletal structure similarto the view depicted in FIG. 106A.

FIG. 112C is a view of the patient's hip skeletal structure similar tothe view depicted in FIG. 103A, except from an opposite lateralperspective.

FIG. 112D is a superior view of the patient's hip skeletal structure.

FIG. 113 is a plan view of a medical kit containing the components ofthe system, namely, the delivery tool, multiple implants of differentsizes, and multiple anchor members of different sizes, wherein thesystem components are sealed within one or more sterile packages andprovided with instructions for using the system.

FIG. 114 is the same transverse cross sectional view of the patient'ship as shown in FIGS. 99A-99Q, except showing the implant havingstructure attached thereto that will allow the implant to serve as anattachment point for structural components of a spinal support systemconfigured to support across the patient's hip structure and/or tosupport along the patient's spinal column.

FIG. 115 is a posterior view of the patient's sacrum and ilium, whereinstructural components of a spinal support system extend medial-lateralacross the patient's hip structure and superiorly to support along thepatient's spinal column.

FIG. 116 is the same view as FIG. 117, except having a differentspanning member structure.

FIG. 117A is a lateral-inferior-posterior view of the patient's hipskeletal structure similar to the view depicted in FIG. 111C.

FIG. 117B is an inferior-posterior view of the patient's hip skeletalstructure similar to the view depicted in FIG. 111A.

FIG. 117C is the same view as FIG. 106B, except showing the implantbeing implanted in the extra-articular space, as opposed to thesacroiliac joint articular region.

FIGS. 118A-118C are, respectively, isometric and opposite plan views ofan implant with a side-to-side deviated bore.

FIGS. 119A-119E are, respectively, distal end isometric, side elevation,plan, distal end elevation, and proximal end elevation views of anotherembodiment of the implant.

FIGS. 120A-120B are, respectively, distal end isometric and sideelevation views of yet another embodiment of the implant.

FIGS. 121A-121G are, respectively, distal end isometric, side elevation,plan, distal end elevation, proximal end elevation, proximal endisometric, and side elevation views of still another embodiment of theimplant.

FIG. 121H is a schematic depiction of a system for fusing a joint,wherein the joint implant includes an electrode in electricalcommunication with a nerve sensing system.

FIG. 122 is a proximal end isometric view of another embodiment of theimplant assembly.

FIGS. 123A-123E are, respectively, distal end isometric, side elevation,plan, distal end elevation, and proximal end elevation views of yetanother embodiment of the implant.

FIGS. 124A and 124B1 are isometric views of another embodiment of thedelivery tool coupled and decoupled with the implant, respectively.

FIG. 124B2 is a cross section view as taken along section line124B2-124B2 in FIG. 124B1.

FIG. 124C is an isometric view of the delivery tool in an explodedstate.

FIG. 124D is an enlarged view of the distal end of the implant arm ofthe delivery tool.

FIGS. 124E-124H are, respectively, distal end isometric, side elevation,plan, and opposite plan views of a version of the embodiment of theimplant of FIGS. 123A-123E, wherein the version includes a bore forreceiving an anchor.

FIG. 125A is an isometric view of another embodiment of the implant.

FIG. 125B is a longitudinal cross section view of the implant of FIG.125A.

FIG. 126A is an isometric view of another embodiment of the implantassembly.

FIG. 126B is a longitudinal cross section view of the implant of FIG.126A.

FIG. 126C is a longitudinal cross section of the proximal head of theanchor of FIG. 126A.

FIG. 127 is an isometric view of an embodiment of a sleeve mounted on animplant arm of a delivery system similar to the delivery system of FIG.88, wherein the sleeve facilitates visualization of the trans screw andtrajectory.

FIG. 128A is an isometric view of another embodiment of the sleeve ofFIG. 127.

FIG. 128B is an end view of sleeve of FIG. 127.

FIG. 128C is a posterior view of the hip region, wherein the sleeve ofFIG. 127 is being employed.

FIGS. 129A-129B show isometric views of another embodiment of thesystem, wherein the delivery tool has a series of interchangeable anchorarms that may be coupled to the implant arm to adjust the tool for thepatient, but maintain the angular relationship between the components ofsystem that allows the anchor member to be delivered into the implantbore and/or another location adjacent to the implant without adjustmentto the delivery tool.

FIG. 129C shows an enlarged view of the arm assembly of the deliverytool of FIGS. 129A-129B.

FIGS. 129D-129K are, respectively, distal end isometric, proximal endisometric, side elevation, opposite side elevation, plan, opposite plan,proximal end elevation, and distal end elevation views of an embodimentof the implant intended for use with the system of FIGS. 129A-129C.

FIG. 129L is an enlarged isometric view of the implant of FIGS.129D-129K mounted on the extreme distal end of the implant arm of thedelivery tool of FIGS. 129A-129C.

FIGS. 129M and 129N are side views of the distal regions of twoalternative implant arms arrangements.

FIG. 129P is an exploded isometric view of the implant arm of FIG. 129M.

FIGS. 130A-130B show anterior views of the hip region with the system ofFIGS. 129A-129C, wherein the ilium is shown and hidden, respectively.

FIGS. 130C-130G show anterior-superior-lateral, posterior, superior,lateral, and inferior views of the hip region with the system of FIGS.129A-129C.

FIGS. 130H and 130I show inferior and posterior-lateral views of apatient, wherein the system of FIGS. 129A-129C is inserted through thesoft tissue of the hip region.

FIGS. 131A-131B show isometric views of another embodiment of thesystem.

FIG. 131C shows an enlarged plan view of the arm assembly of thedelivery tool of FIGS. 131A-131B.

FIGS. 131D-131E are isometric view of a version of the implant of FIGS.129D-121K adapted for use with the delivery system of FIGS. 131A-131C.

FIG. 131F is an isometric view of a version of the implant of FIGS.129D-129K, wherein the body of the implant is hollow and configured towork with a distal end of an implant arm configured to remove cartilage.

FIG. 131G is an isometric view of the distal end of the implant armconfigured to be received in the hollow body of the implant of FIG.131F, wherein the distal end of the implant arm is configured to removecartilage.

FIG. 131H is an isometric view of the implant arm distal end of FIG.131G received in the implant of FIG. 131F.

FIG. 131I is an isometric longitudinal cross section of the implant armdistal end and implant supported thereon as taken along section line131I-131I of FIG. 131H.

FIG. 132A is an isometric view of yet another embodiment of the systemfor fusing a sacroiliac joint.

FIG. 132B is the same view as FIG. 132A, except the system is explodedto better illustrate its components.

FIG. 133A is an isometric view of yet another embodiment of the systemfor fusing a sacroiliac joint.

FIG. 133B shows another isometric view of the system of FIG. 133A.

FIG. 133C shows the same view as FIG. 133B, except the system isinserted through the soft tissue of the hip region of the patient.

FIG. 133D is the same view as FIG. 133C, except the soft tissue ishidden to show the patient bone structure.

FIG. 133E shows a rear elevation view of the system of FIG. 133A.

FIG. 133F shows the same view as FIG. 133E, except the system isinserted through the soft tissue of the hip region of the patient.

FIG. 133G is the same view as FIG. 133F, except the soft tissue ishidden to show the patient bone structure.

FIG. 134A illustrates an embodiment of a system for extracting animplant.

FIGS. 134B-134C show enlarged views of the distal end of the system ofFIG. 134A, wherein the distal end is decoupled and coupled to theimplant, respectively.

FIG. 134D is a longitudinal cross section as taken along section line134D-134D of FIG. 134C.

FIG. 134E is the same view as FIG. 134A, except the system is explodedto better illustrate its components.

FIG. 134F is an isometric view of the proximal end of the implant ofFIGS. 134B-134C.

FIGS. 135A-135C are respectively a first isometric, a second isometricand a plan view of an implant embodiment having a shape that generallymimics or resembles that of a sacroiliac joint space as viewed from asubstantially lateral view.

FIGS. 136A-136D are generally opposite isometric views of an implantembodiment that is configured to transition from a generally linear,rectangular arrangement (shown in FIGS. 136A-136B) to a boot or L-shapedconfiguration (shown in FIGS. 136C-136D) that generally fills and/ormimics the shape of the sacroiliac joint space.

FIG. 136E is an exploded isometric view of the implant of FIGS.136A-136D.

FIGS. 136F and 136G are, respectively, proximal and distal elevations ofthe implant of FIGS. 136A-136D.

FIGS. 136H and 1361 are, respectively, top and bottom plan views of theimplant of FIGS. 136A-136D.

FIG. 1361 is a longitudinal cross sectional elevation of the implant ofFIGS. 136A-136D as taken along section line 136.1-136.1.

FIGS. 136K and 136L are respective enlarged views of the upper and lowercylinder regions of FIG. 1361.

FIGS. 137A and 137B are generally opposite isometric views of an implantembodiment configured to essentially mimic at least a portion of thesacroiliac joint space.

FIGS. 137C-137F are, respectively, a top plan view, a distal endelevation, a side elevation, and a proximal elevation of the implant ofFIGS. 137A and 137B.

FIGS. 138A and 138B are generally opposite isometric views of an implantembodiment configured to essentially mimic at least a portion of thesacroiliac joint space.

FIGS. 138C-138F are, respectively, a top plan view, a distal endelevation, a side elevation, and a proximal elevation of the implant ofFIGS. 138A and 138B.

FIGS. 139-154 are various views of an embodiment of an implant assemblyfor fusing a sacroiliac joint.

FIG. 155 is an isometric view of an implant delivery tool for use withthe implant assembly of FIGS. 139-154.

FIGS. 156 and 157 are exploded views of the implant assembly of FIGS.139-154.

FIGS. 158-163 are various views of an implant delivery tool inaccordance with an embodiment of the present invention.

FIGS. 164-168 are various views of an implant delivery tool inaccordance with another embodiment of the present invention.

FIGS. 169-170 are front and rear perspective views of an implant forfusing a sacroiliac joint in accordance with another embodiment of thepresent invention.

FIGS. 171-173 are various views of an implant for fusing a sacroiliacjoint in accordance with another embodiment of the present invention.

FIG. 174 includes various perspective views of an implant for fusing asacroiliac joint in accordance with yet another embodiment of thepresent invention.

FIGS. 175 and 176 are, respectively, posterior and lateral views of apatient hip region illustrating a surgical approach employing an entrypoint near the coccyx and the sacrotuberous ligament.

FIG. 177 is a posterior-lateral view of the patient hip regionillustrating the delivery tool extending along the surgical approach ofFIGS. 175 and 176.

DETAILED DESCRIPTION

Implementations of the present disclosure involve a system 10 for fusinga sacroiliac joint. The system 10 includes a delivery tool 20 and animplant assembly 15 for delivery to a sacroiliac joint via the deliverytool 20. The implant assembly 15, which includes an implant 25 andanchor 30, is configured to fuse a sacroiliac joint once implanted atthe joint. The tool 20 is configured such that the anchor 30 can bequickly, accurately and reliably delivered to a bore 40 of an implant 25supported off of the tool distal end in a sacroiliac joint.

To begin a detailed discussion of a first embodiment of the system 10,reference is made to FIGS. 2A-3. FIG. 2A is an isometric view of thesystem 10. FIG. 2B is the same view as FIG. 2A, except an implantassembly 15 of the system 10 is separated from a delivery tool 20 of thesystem 10. FIG. 3 is the same view as FIG. 2A, except the system 10 isshown exploded to better illustrate the components of the system 10.

As can be understood from FIGS. 2A and 2B, the system 10 includes adelivery tool 20 and an implant assembly 15 for implanting at thesacroiliac joint via the delivery tool 20, the implant assembly 15 beingfor fusing the sacroiliac joint. As indicated in FIG. 3, the implantassembly 15 includes an implant 25 and an anchor element 30 (e.g., abone screw or other elongated body). As discussed below in greaterdetail, during the implantation of the implant assembly 15 at thesacroiliac joint, the implant 25 and anchor element 30 are supported bya distal end 35 of the delivery tool 20, as illustrated in FIG. 2A. Inone embodiment, the distal end 35 may be fixed or non-removable from therest of the delivery tool 20. In other embodiments, the distal end 35 ofthe delivery tool 20 may be removable so as to allow interchanging ofdifferent sized or shaped distal ends 35 to allow matching to particularimplant embodiments without requiring the use of a different deliverytool 20 and while maintaining the alignment between components (e.g.,anchor 30 aligned with bore 40) The delivery tool 20 is used to deliverthe implant 25 into the sacroiliac joint space. The delivery tool 20 isthen used to cause the anchor element 30 to extend through the ilium,sacrum and implant 25 generally transverse to the sacroiliac joint andimplant 25. The delivery tool 20 is then decoupled from the implantedimplant assembly 15, as can be understood from FIG. 2B.

To begin a detailed discussion of components of an embodiment of theimplant assembly 15, reference is made to FIG. 4, which is a sideisometric view of the implant assembly 15. As shown in FIG. 4, theimplant assembly 15 includes an implant 25 and an anchor element 30. Theanchor element 30 may be in the form of an elongated body such as, forexample, a nail, rod, pin, threaded screw, expanding body, a cable(e.g., configured with a ball end), etc. The anchor element 30 isconfigured to be received in a bore 40 defined through the implant 25.The bore 40 extends through the implant 25 and is sized such that theanchor element 30 can at least extend into or through the implant 25 asillustrated in FIG. 4.

For a detailed discussion of the implant 25, reference is made to FIGS.5-17. FIGS. 5-9 are various isometric views of the implant 25. FIGS. 12and 13 are opposite plan views of the implant 25, and FIGS. 10, 11, 14and 15 are various elevation views of the implant. FIGS. 16 and 17 areisometric longitudinal cross sections of the implant 25 as taken alongcorresponding section lines in FIGS. 11 and 13, respectively.

As shown in FIGS. 5-15, in one embodiment, the implant 25 includes adistal or leading end 42, a proximal or trailing end 43, alongitudinally extending body 45, a bore 40 extending through the body,and keels, fins or planar members 50, 55 that radially extend outwardlyaway from the body 45. In one embodiment, the radially extending planarmembers 50, 55 may be grouped into pairs of planar members 50, 55 thatare generally coplanar with each other. For example, planar members 50that are opposite the body 45 from each other generally exist in thesame plane. More specifically, as best understood from FIGS. 14 and 15,the planar faces 60 of a first planar member 50 are generally coplanarwith the planar faces 60 of a second planar member 50 opposite the body45 from the first planar member 50. Likewise, the planar faces 65 of athird planar member 55 are generally coplanar with the planar faces 65of a fourth planar member 55 opposite the body 45 from the third planarmember 55.

As best understood from FIGS. 14 and 15, one set of planar members 50(i.e., the large planar members 50) may extend radially a greaterdistance D₁ than the distance D₂ extended radially by the other set ofplanar members 55 (i.e., the small planar members 55). Also, the widthW₁ of a large planar member 50 from its outer edge to its intersectionwith the body 45 may be greater than the width W₂ of a small planarmember 55 from its outer edge to its intersection with the body 45.Also, the thickness T₁ of the large planar members 50 may be greaterthan the thickness T₂ of the small planar members 55. Thus, one set ofplanar members 50 may be both wider and thicker than the other set ofplanar members 55. In other words, one set of planar members 50 may belarger than the other set of planar members 55.

In one embodiment, the distance D₁ spanned by the large planar members50 is between approximately 5 mm and approximately 30 mm, with oneembodiment having a distance D₁ of approximately 20 mm, and the distanceD₂ spanned by the small planar members 55 is between approximately 5 mmand approximately 20 mm, with one embodiment having a distance D₂ ofapproximately 14 mm. The width W₁ of a large planar member 50 is betweenapproximately 2.5 mm and approximately 15 mm, with one embodiment havinga width W₁ of approximately 5 mm, and the width W₂ of a small planarmember 55 is between approximately 1 mm and approximately 10 mm, withone embodiment having a width W₂ of approximately 3 mm. The thickness T₁of a large planar member 50 is between approximately 2 mm andapproximately 20 mm, with one embodiment having a thickness T₁ ofapproximately 4 mm, and the thickness T₂ of a small planar member 55 isbetween approximately 1 mm and approximately 10 mm, with one embodimenthaving a thickness T₂ of approximately 2 mm.

As indicated in FIGS. 5-15, the first set of planar members 50 aregenerally perpendicular with the second set of planar members 55. Sincethe sets of planar members 50, 55 are perpendicular to each other, inone embodiment; the intersection of the planar members 50, 55 at acentral longitudinal axis of the implant 25 may form the body 45 of theimplant 25. In other embodiments, and as illustrated in FIGS. 5-14, thebody 45 may be of a distinct shape so as to have, for example, acylindrical or other configuration. In one embodiment, as indicated inFIG. 14, the cylindrical body 45 has a radius R₁ of betweenapproximately 1 mm and approximately 20 mm, with one embodiment having aradius R₁ of approximately 10 mm.

As illustrated in FIG. 12, in one embodiment, the implant 25 has alength L₁ of between approximately 5 mm and approximately 70 mm, withone embodiment having a length L₁ of approximately 45 mm.

As indicated in FIGS. 5 and 9-14, the implant distal end 42 may have abullet nose or otherwise rounded configuration, wherein the roundedconfiguration extends outward away from the distal extremity of the body45 and along the distal or leading edges of the planar members 50, 55.Thus, as can be understood from FIGS. 5 and 9-13, the leading or distaledges 57 of the planar members 50, 55 may be rounded in the radiallyextending length of the lead or distal edges and/or in a directiontransverse to the radially extending length of the lead or distal edges.In one embodiment, the leading edges 57 of the planar members 50, 55each have a radius R₂ of between approximately 1 mm and approximately 15mm, with one embodiment having a radius R₂ of approximately 10 mm. Inone embodiment, the leading end 42 of the implant body 45 and theleading edges 57 of the planar members 50, 55 have a generally conicalpoint configuration.

As indicated in FIGS. 6-8, 10-13, and 15, the implant proximal end 43has a generally planar face that is generally perpendicular to alongitudinal center axis CA of the implant 25. A center attachment bore70 and two lateral attachment bores 75 on opposite sides of the centerbore 70 are defined in the implant proximal end 43. The center bore 70is centered about the longitudinal center axis CA, and the lateralattachment bores 75 are near outer ends of the long planar members 50,generally centered in the thickness of the larger planar members 50.Alternatively, in particular embodiments, the implant proximal end 43can be configured to have a face similarly configured to the implantdistal end 42 (i.e. rounded, bullet nosed, etc.) to allow for asimplified removal of implant 25 during a revision surgery.

As indicated in FIGS. 16 and 17, the center bore 70 may be a blind holein that it only has a single opening. Alternatively, the center bore 70may be configured as a hole that communicates between the implantproximal end 43 and implant bore 40. A center bore so configured may beable to receive a fastener to permit interference with the anchor member30 extending through the bore 40 after implantation to resist migrationof said anchor member.

As illustrated in FIG. 16, the lateral bores 75 are also blind holes andcan be configured to not extend nearly as far into the body 45 as thecenter hole 70 and can be configured to be not nearly as great indiameter as the center hole 70. In one embodiment, the center attachmentbore 70 has a diameter of between approximately 2 mm and approximately10 mm, with one embodiment having a diameter of approximately 5 mm. Inone embodiment, the lateral attachment bores 75 can each have a diameterof between approximately 0.5 mm and approximately 3 mm, with oneembodiment having a diameter of approximately 1.5 mm.

As can be understood from FIG. 17, the implant bore 40, which isconfigured to receive the anchor member 30, has a longitudinal centeraxis BA that is generally transverse to the longitudinal center axis CAof the implant 25. In one embodiment, the implant bore longitudinalcenter axis BA forms an angle A_(BA-CA) with the implant longitudinalcenter axis CA. For example, the angle A_(BA-CA) may be betweenapproximately 15 degrees and approximately 135 degrees, with oneembodiment being approximately 45 degrees.

As shown in FIGS. 4-17, the bore 40 is generally located within a planewith which the small radial planar members 55 are located. That the bore40 is located in the same plane as occupied by the small radial planarmembers 55 is also the case where the bore 40 angularly deviates frombeing perpendicular with the longitudinal axis of the implant body 45.

In one embodiment, the implant 25 may be machined, molded, formed, orotherwise manufactured from stainless steel, titanium, ceramic, polymer,composite, bone or other biocompatible materials. The anchor member 30may be machined, molded, formed or otherwise manufactured from similarbiocompatible materials.

In some embodiments, the implant 25 may be substantially as describedabove with respect to FIGS. 4-17, except the bore 40 of the implant 25may be angled side-to-side relative to the longitudinal axis of theimplant body 45 such that the bore 40 is not contained in the planeoccupied by the small radial planar members 55. For example, as shown inFIGS. 118A-118C, which are, respectively, isometric and opposite planviews of an implant 25 with such a side-to-side deviated bore 40, thebore daylights in the body 45 and large radial planar members 50. Indoing so, the bore 40 deviates side-to-side from the plane in which thesmall planar members 55 are located. Since the bore daylights in thebody 45 and large planar members 50, the bore 40 of FIGS. 118A-118Cdiffers from that of FIGS. 4-17, wherein the bore 40 daylights in thesmall radial members 55.

Just like delivery tool 20 of FIG. 2A has an as-manufacturedconfiguration that allows the anchor arm 115 to deliver the anchorelement 30 to the bore 40 of the implant 25 of FIGS. 4-17 withoutnecessitating modification of the delivery tool 20 configurationsubsequent to the tool 20 leaving its manufacturing facility, a deliverytool 20 can be configured to similarly interact with the bore 40 of theimplant 25 of FIGS. 118A-118C.

In some embodiments, the implant 25 may be substantially as describedabove with respect to FIGS. 4-17, except the implant 25 may furtherinclude an anchor member receiving arm 300. For example, as shown inFIGS. 51-52, which are, respectively, isometric and side elevation viewsof an implant 25 having an anchor member receiving arm 300, the arm 300may be generally cantilevered off of the proximal end 43 of the implant25. The arm 300 includes a free end 305 with a disk-shaped seat 310having a center hole 315 with a center axis that is coaxially alignedwith the center axis BA of the bore 40.

In one embodiment, the arm 300 is rigidly fixed to the implant proximalend 43. In other embodiments, the arm 300 may be in a pivotable orhinged configuration with the implant proximal end 43 to allow movementbetween the implant 25 and arm 300. Such a hinged arm configuration maybe further configured to have a free end 305 which may have a hole 315(or slot). Due to the hinged configuration of the arm, the arm may bepivoted relative to the rest of the implant such that the center axis ofhole 315 may be directed to avoid placing an anchor in a bore 40 or hitthe implant 25. In other words, because of the hinged configuration, thearm may be oriented relative to the rest of the implant such that theaxis of hole 315 directs an anchor 40 around an implant 25 (i.e., theaxis of hole 315 will avoid intersecting the implant 25).

As illustrated in FIG. 53, which is an enlarged view of the disk-shapedseat 310, the disk-shaped seat 310 has a plurality of arcuate members320 distributed along an inner circumferential boundary 325 of a rim 330of the disk-shaped seat 310. There may be five or more or less arcuatemembers 320 distributed generally evenly about the inner circumferentialsurface 325 of the rim 330.

In one embodiment, each arcuate member 320 has ends 332 that intersectthe inner circumferential surface 325 of the rim 330, with a centerpoint 335 of the arcuate member 320 that is offset or spaced apart frominner circumferential surface 325 of the rim 330. Thus, in oneembodiment, the arcuate members 320 may be deflectable so as to allowthe head of the anchor member 30 to pass between the center points 335of the members 330 as the head of the anchor member 30 is seated in theseat 310. As a result, the arcuate members 320 can act against the headof the anchor member 30 to prevent the anchor member from working itsway out of the bore 40 and opening 315 of the implant 25, therebyserving as an anchor member locking mechanism.

Other arms 300 may have an anchor member locking mechanism with adifferent configuration. For example, as illustrated in FIG. 54, whichis an isometric view of an implant 25 with another type of anchor memberlocking mechanism, the arm 300 may be generally cantilevered off of theproximal end 43 of the implant 25. The arm 300 includes a free end 305with a center hole 315 with a center axis that is coaxially aligned withthe center axis BA of the bore 40. As illustrated in FIG. 55, which isan enlarged view of the free end 305, the hole 315 has a cantileveredabutment arm 335 defined in the body of the arm 300 via a series ofparallel arcuate slots 340.

In one embodiment, a face 345 of the abutment arm 335 is deflectable andbiased radially inward of the inner circumferential surface 350 of thehole 315 such that when the anchor member 30 is extended through thehole 315, the face 345 abuts against the anchor member to prevent theanchor member from working its way out of the bore 40 and opening 315 ofthe implant 25, thereby serving as an anchor member locking mechanism.

While in the implant embodiment discussed with respect to FIGS. 4-17 mayhave a cylindrical body 45 at which the planar members 50, 55 intersect,in other embodiments the body 45 of the implant 25 may simply be theregion 45 of the implant 25 where the planar members 50, 55 intersect.For example, as shown in FIGS. 56-61, which are, respectively, frontisometric, rear isometric, side elevation, plan, front elevation, andrear elevation views of an implant 25, the body 45 of the implant 25 issimply the region 45 of the implant 25 where the planar members 50, 55intersect. Although not shown in FIGS. 56-61, in one embodiment, theimplant 25 has the bore 40 and holes 70, 75 substantially as depictedand discussed with respect to the implant of FIGS. 4-17. Also, the restof the features of the implant 25 of FIGS. 56-61 are substantially asdiscussed with respect to the implant 25 of FIGS. 4-17, a maindifference being the lack of the cylindrical body 45 and the edges ofadjacent intersecting surfaces of the implant 25 of FIGS. 56-61 beingrounded or arcuate as opposed to sharp or well-defined edges, as is thecase between adjacent intersecting surfaces of the implant embodiment ofFIGS. 4-17.

Depending on the embodiment, the implant 25 may have surface features ortexture designed to prevent migration of the implant once implanted inthe joint space. For example, as shown in FIGS. 62-67, which are,respectively, front isometric, rear isometric, side elevation, plan,front elevation, and rear elevation views of an implant 25 withanti-migration surface features 355, the body 45 of the implant 25 issimply the region 45 of the implant 25 where the planar members 50, 55intersect. Although not shown in FIGS. 62-67, in one embodiment, theimplant 25 has the bore 40 and holes 70, 75 substantially as depictedand discussed with respect to the implant of FIGS. 4-17. Also, the restof the features of the implant 25 of FIGS. 62-67 are substantially asdiscussed with respect to the implant 25 of FIGS. 56-61, a maindifference being the edges of adjacent intersecting surfaces the implant25 of FIGS. 56-61 being sharp or well defined edges as opposed to roundor arcuate edges, as is the case between adjacent intersecting surfacesof the implant embodiment of FIGS. 56-61.

As to particular embodiments as shown in FIGS. 56-61, and in otherembodiments as disclosed throughout, the implants described herein canbe configured to be used as trials during certain steps of the procedureto determine appropriate implant sizes and to allow a physician, who ispresented with a kit containing the delivery system 20 and multiplesizes of the implant 20, to evaluate particular embodiments of animplant as described herein that would be best suited to a particularpatient, application or implant receiving space.

As shown in FIGS. 62-67, the anti-migration features 355 are generallyevenly distributed along the planar surfaces 60, 65 of the planarmembers 50, 55 in a rows and columns arrangement. The anti-migrationfeatures 355 are generally similarly distributed along the planarsurfaces of the edges of the planar members 55. The anti-migrationfeatures 355 may be in the form of trapezoids, squares, rectangles, etc.As indicated in FIG. 66, the anti-migration features 355 may have arectangular cross sectional elevation with a thickness FT of betweenapproximately 0.2 mm and approximately 5 mm, with one embodiment havinga thickness FT of approximately 1 mm.

As another example, as shown in FIGS. 68-73, which are, respectively,front isometric, rear isometric, side elevation, plan, front elevation,and rear elevation views of an implant 25 with another type ofanti-migration surface features 355, the body 45 of the implant 25 issimply the region 45 of the implant 25 where the planar members 50, 55intersect. Although not shown in FIGS. 68-73, in one embodiment, theimplant 25 has the bore 40 and holes 70, 75 substantially as depictedand discussed with respect to the implant of FIGS. 4-17. Also, the restof the features of the implant 25 of FIGS. 68-73 are substantially asdiscussed with respect to the implant 25 of FIGS. 62-67, including thesharp or well defined edges between adjacent intersecting surfaces ofthe implant 25.

As shown in FIGS. 68-73, the anti-migration features 355 are in the formof unidirectional serrated teeth or ridges 355, wherein the ridges 355have a triangular cross sectional elevation best understood from FIGS.70 and 71, wherein the rearward or trailing end of the features 355 arethe truncated or vertical end of the triangle cross sectional elevation,and the front or leading end of the features 355 are the point end ofthe triangle cross sectional elevation. As indicated in FIG. 71, theanti-migration features 355 with the triangular cross sectionalelevations have a thickness FT of between approximately 0.2 mm andapproximately 5 mm, with one embodiment having a thickness FT ofapproximately 1 mm, and a length FL of between approximately 0.5 mm andapproximately 15 mm, with one embodiment having a thickness FT ofapproximately 2.5 mm. The triangular ridges 355 are generally evenlydistributed along the planar surfaces 60, 65 of the planar members 50,55 in ridges that run transverse to the length of the implant 25. Theanti-migration features 355 are generally similarly distributed alongthe planar surfaces of the edges of the planar members 55.

In continuing reference to FIGS. 68-73, although the anti-migrationfeatures 355 are depicted in the form of unidirectional serrated teethor ridges 355 on each of the textured surfaces of the implant, theinvention is not so limited and, as to particular embodiments, can beconfigured to have said features 355 arranged in multiple directions,unidirectional, or a combination of multiple direction on some surfacesof the implant and unidirectional on other surfaces of the implant.Accordingly, the features 355 can be so arranged on the various surfacesof the implant so as to prevent undesired migration in particulardirections due to the forces present at the sacroiliac joint 1000.

Depending on the embodiment, the implant 25 may have an edgeconfiguration of the planar members 55 designed to prevent migration ofthe implant once implanted in the joint space. For example, as shown inFIGS. 74-79 which are, respectively, front isometric, rear isometric,side elevation, plan, front elevation, and rear elevation views of animplant 25 with anti-migration edges or ends 360, the body 45 of theimplant 25 is simply the region 45 of the implant 25 where the planarmembers 50, 55 intersect. Although not shown in FIGS. 74-79, in oneembodiment, the implant 25 has the bore 40 and holes 70, 75substantially as depicted and discussed with respect to the implant ofFIGS. 4-17. Also, the rest of the features of the implant 25 of FIGS.74-79 are substantially as discussed with respect to the implant 25 ofFIGS. 56-61, with the exception of the anti-migration edges 360 of theimplant embodiment of FIGS. 74-79.

As shown in FIGS. 74-79, the anti-migration edges 360 of the planarmembers 55 are in the form of notches 365 generally evenly distributedalong longitudinally extending free edges or ends of the planar members55. As indicated in FIG. 77, the notches 365 may have parallel sides 370inwardly terminating as an arcuate end 375. The orientation of eachnotch 365 may be such that the center line NL of the notch 365 forms anangle NA with the center axis CA of the implant 25 that is betweenapproximately 90 degrees and approximately 15 degrees, with oneembodiment having an angle NA of approximately 45 degrees. As indicatedin FIG. 77, each notch 365 may have a length LN between the extremepoint on the arcuate end 375 and the outer edge boundary of the notch ofbetween approximately 0.2 mm and approximately 10 mm, with oneembodiment having a length LN of approximately 3 mm. Each notch 365 mayhave a width WN of between approximately 0.5 mm and approximately 20 mm,with one embodiment having a width WN of approximately 2 mm.

As another example, as shown in FIGS. 80-85, which are, respectively,front isometric, rear isometric, side elevation, plan, front elevation,and rear elevation views of an implant 25 with another type ofanti-migration edges or ends 360, the body 45 of the implant 25 issimply the region 45 of the implant 25 where the planar members 50, 55intersect. Although not shown in FIGS. 80-85, in one embodiment, theimplant 25 has the bore 40 and holes 70, 75 substantially as depictedand discussed with respect to the implant of FIGS. 4-17. Also, with theexception of its anti-migration edges 360 and its more arcuate distal orleading end 42, the rest of the features of the implant 25 of FIGS.80-85 are substantially as discussed with respect to the implant 25 ofFIGS. 62-67, including the sharp or well defined edges between adjacentintersecting surfaces of the implant 25.

As shown in FIGS. 80-85, the anti-migration edges 360 are flaredlongitudinally extending free edges or ends of the planar members 55.The edges 360 include a series of ridges 370 that are generally evenlydistributed along the length of the edges 360 and oriented transverse tothe length of the edges 360.

As indicated in FIG. 83, the ridges 370 have triangular cross sectionalelevations with an overall height RA of between approximately 0.2 mm andapproximately 8 mm, with one embodiment having a width RA ofapproximately 1 mm. As illustrated in FIG. 85, the flared longitudinallyextending free edges or ends of the planar members 55 have rim edges 380defining the top and bottom edges of the anti-migration edges 360 of theplanar members 55, wherein the rim edges 380 have slopes 385transitioning between the planar surfaces 65 of the planar members 55and the rim edges 380.

The edges 360 have a height EH between the edges 380 of betweenapproximately 0.5 mm and approximately 15 mm, with one embodiment havinga height EH of approximately 4 mm. The width EW of the flared edge 360from the beginning of the sloped transition 385 to the face of the edge360 is between approximately 0.2 mm and approximately 9 mm, with oneembodiment having a width EW of approximately 1 mm.

In particular embodiments, the implants with features as described abovewith respect to FIGS. 62-83 can alternatively be configured to functionas a broach or other surgical site preparation tool that can assist inthe removal of certain tissues, for example, cartilage or bone, duringcertain steps of a procedure.

To begin a detailed discussion of components of an embodiment of thedelivery tool 20, reference is again made to FIGS. 2A-3. As shown inFIG. 2A, the delivery tool 20 includes a distal end 35 and a proximalend 80. The distal end 35 supports the implant assembly 15 components25, 30, and the proximal end 80 is configured to be grasped andmanipulated to facilitate the implantation of the implant assembly 15 inthe sacroiliac joint.

As illustrated in FIG. 3, the delivery tool 20 further includes an armassembly 85, a handle 90, an implant retainer 95, a sleeve 100 and atrocar or guidewire 105. As shown in FIG. 18, which is a proximalisometric view of the arm assembly 85, the arm assembly 85 includes animplant arm 110 and an anchor arm 115 supported off of the implant arm110. The implant arm 110 includes a distal end 120, a proximal end 125and a proximal cylindrical opening 130 of a cylindrical bore 132. Theproximal end 125 includes a squared outer surface configuration 135 thatfacilitates a mechanical engagement arrangement with the handle 90 suchas the mechanical arrangement that exists between a wrench and nut.

As shown in FIG. 19, which is a distal isometric view of the armassembly 85, the distal end 120 includes cylindrical opening 137 of acylindrical bore 132, large planar members, keels, or fins 140 and smallplanar members, keels, or fins 145, pins 150, and a planar extremedistal face 152. As depicted in FIG. 20, which is a longitudinal crosssection of the implant arm 110 as taken along section line 20-20 in FIG.18, the cylindrical bore 132 extends the full length of the implant arm110 between the proximal opening 135 and the distal opening 137.

For a detailed discussion of the interaction between the features of theimplant arm distal end 120 and the proximal end 43 of the implant 25,reference is now made to FIGS. 2A and 21A and 22-24. FIG. 21A is a sideelevation of the system 10 wherein the tool 20 is attached to theimplant assembly 15 for delivery of the implant assembly 15 to thesacroiliac joint. FIG. 22 is the same view as FIG. 21A, except shown asa longitudinal cross section. FIG. 23 is an enlarged view of the distalregion of the system 10 circled in FIG. 22. FIG. 24 is an enlarged crosssectional plan view taken in a plane 90 degrees from the section planeof FIG. 23.

As can be understood from FIGS. 2A and 21A and 22-24, when the system 10is assembled for the delivery of the implant assembly 15 to thesacroiliac joint, the proximal end 43 of the implant 25 (see FIG. 6) issupported off of the implant arm distal end 120 (see FIG. 19). As can beunderstood from a comparison of FIGS. 6 and 19 and more clearly depictedin FIGS. 23 and 24, the cylindrical body 45, and planar members 50, 55of the implant 25 and the cylindrical implant arm 110 and planar members140, 145 of the implant arm 110 respectively correspond with respect toboth shape and size such that when the implant 25 is supported off ofthe implant arm distal end 120 as depicted in FIGS. 2A and 21A and22-24, the respective outer surfaces of the implant 25 and implant armdistal end 120 transition smoothly moving from the implant 25 to theimplant arm distal end 120, and vice versa. Also, as shown in FIGS. 23and 24, when the system 10 is assembled for the delivery of the implantassembly 15 to the sacroiliac joint, the planar extreme proximal face 43of the implant 25 abuts against the planar extreme distal face 152 ofthe implant arm distal end 120, the pins 150 being received in arecessed fashion in the lateral bores 75. The pins 150 being received inthe lateral bores 75 prevents the implant 25 from pivoting relative tothe implant arm 110. The pins 150 can be configured to have arectangular, circular or any other cross section and the correspondinglateral bores 75 can also be configured to have corresponding shapes incross section.

Alternatively, in order to further restrict undesirable movement betweencomponents of a system 10, namely between that of a delivery tool 20 andan implant 25, the distal face 152 of the implant arm distal end 120 canbe configured to rap around, and can also be recessed into or grappledto, the exterior surface of the elongate body 45, or planar members 50,or 55 of the implant 25 a distance DE, from about 0.2 mm to about 20 mm(e.g., 10 mm), in the direction of implant distal end 42. According toparticular embodiments, a recess can extend a distance DA from saidexterior surfaces in the general direction of implant longitudinal axisCA, from about 0.25 mm to 5 mm (e.g., 1.25 mm). In a non-limitingexample of a particular embodiment, the distal face 152 of the implantarm distal end 120 can be further configured to wrap completely or onlya portion of the periphery of an implant by occupying only a portion,CAR, as defined by a number of degrees around implant longitudinal axisCA, from about 1 degree to about 180 degrees (e.g., 30 degrees). Inparticular embodiments, said features can be configured to be located inthe area between the planar members 50 and 55.

As shown in FIGS. 18 and 19, the anchor arm 115 is supported off of theimplant arm 110 at an angle and includes a proximal end 155 and a distalend 160 distally terminating in a sleeve or collar 165 having alongitudinal center axis LCA₁ that is generally transverse to thelongitudinal axis of the anchor arm 115. Collar 165 has a length ofbetween approximately 10 mm and approximately 60 mm (e.g., 20 mm)disposed between collar ends 166 and 167 configured to permit andmaintain accurate alignment of the first sleeve 100 along LCA₁ duringthe course of the procedure. The anchor arm proximal end 155 intersectsthe implant arm 110 at a location between the proximal and distal endsof the implant arm.

As indicated in FIGS. 18 and 19, the implant arm 110 also includes alongitudinal center axis LCA₂. As shown in FIG. 21A, when the system 10is assembled such that the implant 25 is mounted on the distal end ofthe implant arm 110, the longitudinal center axis CA of the implant 25is coaxially aligned with the longitudinal center axis LCA₂ of theimplant arm 110, and the longitudinal center axis BA of the implant bore40 is coaxially aligned with the longitudinal center axis LCA₁ of theanchor arm collar 165. Thus, the longitudinal center axis CA of theimplant 25 and the longitudinal center axis LCA₂ of the implant arm 110exist on a first common longitudinally extending axis, and thelongitudinal center axis BA of the implant bore 40 and the longitudinalcenter axis LCA₁ of the anchor arm collar 165 exist on a second commonlongitudinally extending axis.

In one embodiment, the longitudinal center axis LCA₁ of the anchor armcollar 165 forms an angle A_(LCA1-LCA2) with the longitudinal centeraxis LCA₂ of the implant arm 110. For example, the angle A_(LCA1-LCA2)may be between approximately 15 degrees and approximately 135 degrees,with one embodiment being approximately 45 degrees.

As can be understood from FIG. 21A, when the system 10 is assembled suchthat the implant 25 is mounted on the distal end of the implant arm 110,the longitudinal center axis LCA₂ of the implant arm 110 is coaxial withthe longitudinal center axis CA of the implant 25 and the longitudinalcenter axis of the handle 90. Thus, the line of action for the insertionof the implant 25 into the sacroiliac joint is coaxial with thelongitudinal center axes of the implant 25, implant arm 110 and handle90.

As can be understood from the preceding discussion, in one embodiment,when the system 10 is assembled such that the implant 25 is mounted onthe distal end of the implant arm 110, the angle A_(BA-CA) may besubstantially the same as the angle A_(LCA1-LCA2). Also, thelongitudinal center axis BA of the implant bore 40 is coaxially alignedwith the longitudinal center axis LCA₁ of the anchor arm collar 165.Thus, as will be described in detail below, the anchor arm collar 165 isoriented so as to guide drills and other tools in creating a channelthrough tissue and bone leading to the implant bore 40 when the implant25 is positioned in the sacroiliac joint while the implant 25 is stillattached to the distal end of the implant arm 110, as shown in FIG. 21.Additionally, the anchor arm collar 165 is oriented so as to guide theanchor member 30 into the implant bore 40 when the implant 25 ispositioned in the sacroiliac joint while the implant 25 is stillattached to the distal end of the implant arm 110, as shown in FIG. 21A.

As can be understood from FIG. 21A, in one embodiment, theabove-described coaxial and angular relationships are rigidly maintaineddue to the anchor arm 115 and its collar 165 being in a fixed,non-adjustable configuration, and the interconnection between theproximal end of the anchor arm 115 and the implant arm 110 being afixed, non-adjustable configuration at least with respect to the angleA_(LCA1-LCA2) between the longitudinal center axis LCA₁ of the anchorarm collar 165 and the longitudinal center axis LCA₂ of the implant arm110. Thus, in one embodiment, the delivery tool 20 comes from themanufacture to the physician in a fixed, non-adjustable configurationhaving the coaxial and angular relationships articulated above withrespect to FIG. 21A.

FIG. 21B is the same view as FIG. 21A, except of another embodiment ofthe delivery tool 20 wherein the tool 20 includes multiple anchor arms115A-115D that can be coupled to specific respective locations 168A-168Don the implant arm 110 to account for different patient sizes, yet stillmaintain the coaxial and angular relationships set out above. As shownin FIG. 21B, the delivery tool 20 may include two or more, for example,four, anchor arms 115A-115D, each anchor arm having a different overalllength. Despite having different overall lengths, because each anchorarm 115A-115D is configured to couple to a specific respective location168A-168D on the implant arm 110, the longitudinal center axis LCA₁ ofeach anchor arm collar 165A-165D is still coaxially aligned with thelongitudinal center axis BA of the implant bore 40 when each anchor armis mounted at its correct respective location 168A-168D on the implantarm 110. Thus, although the embodiment depicted in FIG. 21B isadjustable with respect to patient size via the interchangeable anchorarms 115A-115D, the above-described coaxial and angular relationshipsare rigidly maintained due to the anchor arms 115A-115D and theircollars 165 being in a fixed, non-adjustable configuration, and theinterconnection between the proximal end of the anchor arms 115A-115Dand the implant arm 110 being, a fixed, non-adjustable configuration atleast with respect to the angle A_(LCA1-LCA2) between the longitudinalcenter axis LCA₁ of the anchor arm collar 165 and the longitudinalcenter axis LCA₂ of the implant arm 110. Thus, although the embodimentdepicted in FIG. 21B is adjustable with respect to the patient size viathe interchangeable anchor arms 115A-115D, the delivery tool 20 comesfrom the manufacture to the physician in a fixed, non-adjustableconfiguration with respect to the coaxial and angular relationshipsarticulated above with respect to FIG. 21A.

Although not shown in FIG. 21B, in some embodiments, multiple sleeves100 may be provided with the system 10. For example, the system 10 mayinclude four anchor arms 165A-165D of different lengths and the systemmay also include four sleeves 100 of different lengths, each sleeve 100being configured for use with a specific anchor arm. For example, sinceanchor arm 165D is the longest anchor arm, its corresponding sleeve 100may be the longest of the sleeves. Similarly, since anchor arm 165A isthe shortest anchor arm, its corresponding sleeve 100 may be theshortest of the sleeves.

Because of the multiple interchangeable anchor arms 165A-165D that areeach configured for attachment to a specific respective location168A-168D on the implant arm 110, the delivery tool 20 may be adjustedto accommodate patients of different sizes and still maintain theangular relationships between the components of system 10 that allowsthe anchor member 30 to be delivered into the implant bore 40 withoutany further adjustment to the delivery tool. Because the angularrelationships are rigidly maintained between the arms 110, 115, thecollar 165, and the implant bore 40 despite the anchor arms 115A-115Bbeing interchangeable, the anchoring of the implant 25 in the sacroiliacjoint via the anchor member 30 may be achieved quickly and safely. Inother words, because the tool does not need to be adjusted with respectto angular relationships, the surgery is simplified, reduced induration, and reduces the risk of the anchor member 30 being driventhrough a nerve, artery or vein.

In some embodiments, the system 10 may be provided with two or moretools 20, each tool having a configuration for a specific size ofpatient. For example, the tool 20 depicted in FIG. 21A may be providedfor smaller patients in that there is reduced distance between theanchor arm collar 165 and the implant 25. As depicted in FIG. 21C, whichis the same view of FIG. 21A, except illustrating a version of the sametool 20 configured to accommodate larger patients, the distance betweenanchor arm collar 165 and implant 25 is greater due to the anchor arm165 being more proximally located on the implant arm 110 as compared tothe configuration depicted in FIG. 21A. It should be noted that,although the version depicted in FIG. 21C is configured to accommodatelarger patients, the coaxial and angular relationships discussed abovewith respect to FIG. 21A are the same for the version depicted in FIG.21C. For the version depicted in FIG. 21C, the sleeve 100 issubstantially elongated as compared to the sleeve 100 of FIG. 21A.Depending on the size of the patient, the physician may select or beprovided with one of the tool configurations shown in FIG. 21A or 21C.

Additionally, the sleeve 100 of FIG. 21C can be prevented from undesiredmigration within the anchor arm collar 165 during a procedure byutilizing a locking mechanism 163 in close proximity to the collar 165.As a non-limiting example, a locking mechanism can be configured as afastener 163, which, in certain embodiments, can be threaded androtatably advanced into the collar 165 to cause a greater amount offriction upon the sleeve 100.

As shown in FIGS. 25-27, which are various isometric views of the handle90, the handle 90 includes a gripping portion 170, a neck portion 175, aproximal end 180, a distal end 185, a proximal opening 190, a distalopening 195 and a bore 200 extending longitudinally through the handle90 between the openings 190, 195. The proximal opening 190 is defined inthe proximal end 180, which forms the extreme proximal portion of thegripping portion 170. The distal opening 195 is defined in the distalend 185, which forms the extreme distal portion of the neck portion 175.The neck portion 175 has multiple regions having different diameters,thereby forming a collared configuration. The gripping portion 170 mayhave a generally spherical or oval hemispheric shape.

As shown in FIG. 27, a squared inner surface configuration 205 isdefined in a segment of the bore 195 located in the neck portion 175,the rest of the bore 195 having a cylindrical configuration. Thus, ascan be understood from FIGS. 1, 21A and 22, when the implant arm distalend 125 is received in the handle bore 200, the squared inner surfaceconfiguration 205 facilitates a mechanical engagement arrangement withthe squared outer surface configuration 135 of the implant arm distalend 125. As a result, grasping the handle so as to cause the handle topivot about its longitudinal center axis causes the implant arm tosimilarly pivot about its longitudinal center axis, which is generallycoaxial with the longitudinal center axis of the handle. The fit betweenthe squared surface configurations 135, 205 may be such as to form aninterference fit, thereby preventing the handle from being pulled off ofthe implant arm distal end without the intentional application ofsubstantial separating force.

As illustrated in FIGS. 28 and 29, which are full isometric andlongitudinal cross sectional isometric views of the implant retainer 95,the implant retainer 95 includes a longitudinal cylindrical member 210,T-handle 215 on a proximal end of the longitudinal cylindrical member210, and an implant engagement feature 220 on a distal end thelongitudinal cylindrical member 210. As can be understood from FIGS. 2Aand 21A and 22-24, when the system 10 is assembled for the delivery ofthe implant assembly 15 to the sacroiliac joint, the longitudinalcylindrical member 210 extending through the handle bore 200 (see FIG.27) and implant arm bore 132 (FIG. 20) such that a distal side of theT-handle 215 abuts or nearly abuts with the handle proximal face or end180 (FIG. 25) and the implant engagement feature 220 is received in theimplant center bore 70 (FIG. 6). In one embodiment, the implantengagement feature 220 is in the form of a threaded shaft for engagingcomplementary threads in the center bore 70, thereby securing theimplant proximal face against the implant arm distal face and the pinsin the lateral bores, as depicted in FIGS. 22-24. In other embodiments,the implant engagement feature 220 and the center bore 70 are configuredso as to form an interference fit between the two such that anintentional separating force is required to remove the implantengagement feature from within the center bore and allow the release ofthe implant from the distal end of the implant arm, as indicated in FIG.2B.

FIG. 30A is an isometric view of a sleeve 100 that is configured to bereceived in the anchor arm collar 165, as can be understood from FIGS.2A, 21A, and 22-23. The sleeve 100 may have a tubular portion 225 thatextends from a plate 230 and defines a lumen 226 extending the length ofthe tubular portion 225. As indicated in FIG. 30B, which is alongitudinal cross section of one embodiment of the sleeve 100, thesleeve 100 is formed of multiple sleeve portions 100A-100C nestedtogether such that the tubular portions 225A-225B are concentricallyarranged and the plates 230A-230B are stacked. As each sleeve portion100A-100C has a tubular portion 225A-225B with a different diameter, thesleeve portions 100A-100C can be employed as needed to dilate anincision opening or guide different diameter guidewires, trocars,drills, etc. in the direction of the implant bore 40.

FIG. 31 is an isometric view of a trocar, guidewire, drill, screwdriver,etc. that may be inserted through the lumen 226 of the tubular portion225 in gaining access to, or driving the anchor member 30 into, theimplant bore 40 when the implant 25 is positioned in the sacroiliacjoint via the distal end of the implant arm 110.

To begin a detailed discussion of a second embodiment of the system 10,reference is made to FIGS. 32-33. FIG. 32 is an isometric view of thesystem 10, and FIG. 33 is the same view as FIG. 32, except the system 10is shown exploded to better illustrate the components of the system 10.

As can be understood from FIGS. 32 and 33, the system 10 includes adelivery tool 20 and an implant assembly 15 for implanting at thesacroiliac joint via the delivery tool 20, the implant assembly 15 beingfor fusing the sacroiliac joint. As indicated in FIG. 33, the implantassembly 15 includes an implant 25 and an anchor element 30 (e.g., abone screw or other elongated body). In one embodiment, the implantassembly 15 is the same as that described above with respect to FIGS.4-17. As discussed below in greater detail, during the implantation ofthe implant assembly 15 at the sacroiliac joint, the implant 25 andanchor element 30 are supported by a distal end 35 of the delivery tool20, as illustrated in FIG. 32. The delivery tool 20 is used to deliverthe implant 25 into the sacroiliac joint space. The delivery tool 20 isthen used to cause the anchor element 30 to extend through the ilium,sacrum and implant 25 generally transverse to the sacroiliac joint andimplant 25. The delivery tool 20 is then decoupled from the implantedimplant assembly 15.

As shown in FIG. 32, the delivery tool 20 includes a distal end 35 and aproximal end 80. The distal end 35 supports the implant assembly 15components 25, 30, and the proximal end 80 is configured to be graspedand manipulated to facilitate the implantation of the implant assembly15 in the sacroiliac joint.

As illustrated in FIG. 33, the delivery tool 20 further includes an armassembly 85, a handle 90, an implant retainer 95, and a trocar orguidewire 105. As shown in FIG. 33 and also in FIG. 34, which is a sideelevation of the system 10, the arm assembly 85 includes an implant arm110 and an anchor arm 115.

As shown in FIG. 35, which is a proximal isometric view of the implantarm 110, the implant arm 110 includes a distal end 120, a proximal end125 and a proximal cylindrical opening 130 of a cylindrical bore 132.The proximal end 125 includes a squared outer surface configuration 135that facilitates a mechanical engagement arrangement with the handle 90such as the mechanical arrangement that exists between a wrench and nut.As the handle 90 is the same as described above with respect to FIGS.25-27, the handle 90 receives and mechanically interlocks with thedistal region of the implant arm 110 as described above with respect toFIG. 22.

As with the implant arm 110 discussed above with respect to FIG. 19 andas can be understood from FIG. 34, the distal end 120 of the implant arm110 includes a cylindrical opening 137 (see FIG. 19) of a cylindricalbore 132, large planar members, keels, or fins 140 and small planarmembers, keels, or fins 145, pins 150, and a planar extreme distal face152 (see FIG. 19). Just as explained with respect to FIG. 20 above, thecylindrical bore 132 of the embodiment depicted in FIG. 34 extends thefull length of the implant arm 110 between the proximal opening 135 andthe distal opening 137.

As the retaining member 95 of the embodiment of FIG. 33 is the same asdescribed above with respect to FIGS. 28-29, the retainer member 95extends through the handle 90 and implant arm 110 to mechanicallyinterlock with the implant center bore 70 as described above withrespect to FIGS. 22-24. Also, the configuration of the distal end 120 ofthe implant arm 110 of FIG. 35 is the same as the configuration of thedistal end 120 of the implant arm 110 of FIG. 19. Accordingly, thedistal end 120 of the implant arm 110 of FIG. 35 interacts with theproximal end of the implant 25 as describe above with respect to FIGS.22-24.

As indicated in FIG. 35, the implant arm 110 includes pivot pins 235 onopposite sides of the implant arm 110, the pivot pins 235 having a pivotaxis PA that is perpendicular to the plane in which the implant bore 40passes through the implant 25. In other words, the pivot axis PA isperpendicular to the longitudinal center axis LCA₂ of the implant arm110 and contained within the same plane as the longitudinal center axisLCA₂ of the implant arm 110. The pivot pins 235 are located on theimplant arm 110 near the distal end of the handle 90.

As illustrated in FIG. 36, which is an isometric view of the anchor arm115, the anchor arm 115 includes a proximal end 155 and a distal end 160distally terminating in a sleeve or collar 165 that is arcuate andsubstantially extended as compared to the collar 165 of the embodimentdepicted in FIG. 18. The arcuate and extended collar 165 has an arcuatelongitudinal center axis LCA_(T) that is generally transverse to thelongitudinal axis of the anchor arm 115. A lumen 236 extends the lengthof the collar 165 to daylight in openings at both ends of the collar165.

As shown in FIG. 36, the anchor arm proximal end 155 includes notches240, which, as can be understood from FIGS. 32 and 34, receive therespective pivot pins 235. As a result, the anchor arm 115 is pivotallysupported off of the implant arm 110 via the notches 240 at the anchorarm proximal end 155 pivotally receiving the pivot pins 235 of theimplant arm 110.

As can be understood from FIGS. 32-34, an arcuate member 105 can beinserted in the lumen 236 of the arcuate extended collar 165. Thecurvature of the arcuate member 105 matches the curvature of the lumen236 of the arcuate collar 165. The arcuate member 105 may be a trocar,guidewire, drill, screwdriver, etc. that may be inserted through thelumen 236 of the collar 165 in gaining access to, or driving the anchormember 30 into, the implant bore 40 when the implant 25 is positioned inthe sacroiliac joint via the distal end of the implant arm 110. Asindicated by the arrow A in FIG. 34, the arcuate member 105 is slidablydisplaceable through the arcuate length of the collar 165. Also, asindicated by arrow B, the anchor arm 110 is pivotal about the pivot pins235.

As indicated in FIG. 35, the implant arm 110 includes a longitudinalcenter axis LCA₂. As shown in FIG. 34, when the system 10 is assembledsuch that the implant 25 is mounted on the distal end of the implant arm110, the longitudinal center axis CA of the implant 25 is coaxiallyaligned with the longitudinal center axis LCA₂ of the implant arm 110,and the longitudinal center axis BA of the implant bore 40 is coaxiallyaligned with the longitudinal center axis LCA₁ of the anchor arm collar165. In other words, in the context of the embodiment of FIG. 34, thearcuate longitudinal center axis LCA₁ extends to be coaxially alignedwith the longitudinal center axis BA of the implant bore 40. In oneembodiment, as indicated in FIG. 34, the longitudinal center axis LCA₁of the anchor arm collar 165 has an arm radius R_(ARM) that extends intocoaxial alignment with the longitudinal center axis BA of the implantbore 40. For example, the arm radius R_(ARM) may be betweenapproximately 50 mm and approximately 300 mm, with one embodiment beingapproximately 160 mm.

As can be understood from FIG. 34, when the system 10 is assembled suchthat the implant 25 is mounted on the distal end of the implant arm 110,the longitudinal center axis LCA₂ of the implant arm 110 is coaxial withthe longitudinal center axis CA of the implant 25 and the longitudinalcenter axis of the handle 90. Thus, the line of action for the insertionof the implant 25 into the sacroiliac joint is coaxial with thelongitudinal center axes of the implant 25, implant arm 110 and handle90. Thus, as will be described in detail below, the anchor arm collar165 is oriented so as to guide drills and other tools in creating achannel through tissue and bone leading to the implant bore 40 when theimplant 25 is positioned in the sacroiliac joint while the implant 25 isstill attached to the distal end of the implant arm 110, as shown inFIG. 34. Additionally, the anchor arm collar 165 is oriented so as toguide the anchor member 30 into the implant bore 40 when the implant 25is positioned in the sacroiliac joint while the implant 25 is stillattached to the distal end of the implant arm 110, as shown in FIG. 32.

Because the tool embodiment depicted in FIG. 32 has an anchor arm 115that is pivotally supported off of the implant arm 110 and the anchorarm collar 165 is arcuate and slidably receives an arcuate trocar, etc.105, the tool 20 is able to account for different patient sizes, yetstill maintain the coaxial and angular relationships set out above. Inother words, regardless of whether the anchor arm 115 is pivoted so asto move the anchor arm distal end 160 closer to or further away from theimplant bore 40 to accommodate a smaller or larger patient, the trocar105 can be withdrawn from or extended towards the implant bore 40 asneeded to deliver the anchor 30 to the implant bore 40, the trocar 105being maintained in the necessary coaxial alignment of the longitudinalaxis LCA₁ of the collar 165 with the longitudinal axis BA of the implantbore 40.

Because the angular relationships are rigidly maintained between thetrocar 105 and the implant bore 40 despite the anchor arm 115 beingpivotal relative to the implant arm, the anchoring of the implant 25 inthe sacroiliac joint via the anchor member 30 may be achieved quicklyand safely. In other words, because the tool does not need to beadjusted with respect to angular relationships, the surgery issimplified, reduced in duration, and reduces the risk of the anchormember 30 being driven through a nerve, artery or vein.

To begin a detailed discussion of a third embodiment of the system 10,reference is made to FIGS. 37-40. FIGS. 37 and 38 are differentisometric views of the system 10. FIG. 39 is the same view as FIG. 37,except the system 10 is shown exploded to better illustrate thecomponents of the system 10. FIG. 40 is a side elevation of the systemwherein the tool is attached to the implant assembly for delivery of theimplant assembly to the sacroiliac joint.

As can be understood from FIGS. 37-40, the system 10 includes a deliverytool 20 and an implant assembly 15 for implanting at the sacroiliacjoint via the delivery tool 20, the implant assembly 15 being for fusingthe sacroiliac joint. As indicated in FIG. 39, the implant assembly 15includes an implant 25 and an anchor element 30 (e.g., a bone screw orother elongated body).

As can be understood from a comparison of FIGS. 2A-3 to FIGS. 37-40, thedelivery tool 20 of FIGS. 2A-3 is the same as the delivery tool 20 ofFIGS. 37-40. Thus, for a complete description of the delivery tool 20 ofFIGS. 37-40 and its components, namely, the arm assembly 85, handle 90,implant retainer 95, a trocar or guidewire 105, and multiple nestedsleeves 100, refer back to the corresponding discussion given above withrespect to FIGS. 2A-3 and 18-31.

As indicated in FIGS. 37-40, the system 10 includes an implant assembly15 with an implant 25 similar the implant 25 discussed above withrespect to FIGS. 4-18, except the implant 25 of FIGS. 37-40 alsoincludes a guide arm 265. To begin a detailed discussion of componentsof the embodiment of the implant 25 of FIGS. 37-40, reference is made toFIGS. 41-50. FIGS. 41-44 are various isometric views of the implant 25.FIGS. 45-46 are opposite plan views of the implant 25, and FIGS. 47-50are various elevation views of the implant.

A comparison of FIGS. 41-50 to FIGS. 5-18 reveals that the two implantembodiments are the same, except the implant embodiment of FIGS. 41-50has a guide arm 265. Thus, for a complete description of the features ofthe implant 25 other than the guide arm 265, which is discussed below,refer back to the corresponding discussion given above with respect toFIGS. 5-18.

As shown in FIGS. 41-45 and 46-50, the guide arm 265 includes alongitudinally extending member 270 and a guide portion 275. The guidearm 265 is cantilevered off of a side of the implant near the proximalor trailing end 43 of the implant 25. Thus, the guide arm 265 includesan attached end 280, which is attached to, or extends from, the implantproximal end 43, and a free end 285, which defines the guide portion275.

The longitudinally extending member 270 may be in the form of a planarmember or other shaped member. As illustrated in FIG. 45, thelongitudinal axis LA of the member 270 is generally coplanar with thelongitudinal axis CA of the implant body 45. However, as indicated inFIG. 48, the longitudinal axis LA of the member 270 forms an angleA_(LA-CA) with the longitudinal axis CA of the implant body 45. Forexample, the angle A_(LA-CA) may be between approximately 5 degrees andapproximately 60 degrees, with one embodiment being approximately 40degrees.

As illustrated in FIGS. 41-45 and 47-50, the guide portion 275 is in theform of a collar defining a central hole 290. As indicated in FIG. 47,the member 270 has an overall length AD from its intersection with therest of the implant to the tip of the free end 285 of betweenapproximately 5 mm and approximately 60 mm, with one embodiment beingapproximately 20 mm. Also, the center axis GA of the hole 290 iscoaxially aligned with the center axis BA of the bore 40. The overalllength AE from the intersection of the member 270 with the rest of theimplant to the center axis GA is between approximately 2 mm andapproximately 58 mm, with one embodiment being approximately 17 mm.

Since the center axis GA of the hole 290 is coaxially aligned with thecenter axis BA of the bore 40, when the system 10 is assembled such thatthe implant 25 is mounted on the distal end of the implant arm 110 withthe longitudinal center axis LCA₂ of the implant arm 110 coaxial withthe longitudinal center axis CA of the implant 25, the respectivelongitudinal axes LCA₁, BA and GA of the anchor arm collar 165, the bore40 and the guide hole 290 are coaxially aligned, as can be understoodfrom FIG. 40. Thus, when the implant body 45 is located in thesacroiliac joint and the guide collar 275 of the implant 25 is locatednear or against bone adjacent to the sacroiliac joint, the anchor member30 may be accurately driven through the guide hole 290, through the boneand through the implant bore 40 to anchor the implant at the sacroiliacjoint in such a manner to allow the implant to fuse the joint.

In one embodiment, the implant 25 may be machined, molded, formed, orotherwise manufactured from stainless steel, titanium, ceramic, polymer,composite or other biocompatible materials. The anchor member 30 may bemachined, molded, formed or otherwise manufactured from similarbiocompatible materials. As an example, implant 25, anchor 30 ordelivery tool 20 may be manufactured by laser or electron beam additivemanufacturing with, for example, EOSINT P 800 or EOSINT M 280 (availablefrom EOS GmbH, Electro Optical Systems, Robert-Stirling-Ring 1, D-82152Krailling/Munich), or Arcam A1 (available from Arcam AB (publ.),Krokslatts Fabriker 27A, SE-431 37 Molndal Sweden).

For the delivery tools 20 depicted in FIGS. 2A, 21A, 21C, 32, 37, and40, the handle 90 and arm assembly 85 are coupled together so as to notallow rotational movement relative to each other, and the implantretainer 95 is rotationally displaceable within the handle 90 and armassembly 85. In other embodiments of the tool 20, the handle 90 andimplant retainer 95 are coupled together so as to rotate as a unitrelative to the arm assembly 85. An example of such an embodiment isillustrated in FIG. 86, which is an isometric view of the delivery tool20.

As shown in FIG. 86, the delivery tool 20 includes a distal end 35 and aproximal end 80. As shown in FIGS. 87-88, which are generally oppositeisometric views of the delivery tool 20 in an exploded state, the tool20 further includes an arm assembly 85, a handle 90, an implant retainer95, and a collar assembly 400. The tool 20 may also include a sleeve 100and a trocar or guidewire 105 as discussed above with respect to theembodiment of FIG. 3.

As can be understood from FIGS. 86-88, the arm assembly 85 includes animplant arm 110 and an anchor arm 115 supported off of the implant arm110. The implant arm 110 has a two-piece construction of an inner sleeve110A and an outer sleeve 110B. The implant arm inner sleeve 110Aincludes a distal end 120, a proximal end 125, a proximal cylindricalopening 130 of a cylindrical bore 132, and a distal cylindrical opening137 of the bore 132. The cylindrical bore 132 extends the full length ofthe implant arm inner portion 110A between the proximal opening 135 andthe distal opening 137. Longitudinally extending raised ribs 405 areradially distributed about the outer circumferential surface of theimplant arm inner portion 110A. The longitudinal ribs 405 distallyterminate by intersecting a raised circumferential ring 410 on the outercircumferential surface of the inner implant arm portion 110A. A groove415 is circumferentially extends about the outer circumference of theimplant arms inner portion 110A. The distal end 120 of the implant arminner portion 110A also includes large planar members, keels, or fins140 and small planar members, keels, or fins 145, pins 150, and a planarextreme distal face 152 similar to that discussed above with respect tothe embodiment of FIG. 2A.

As illustrated in FIGS. 87-88, the implant arm outer portion 110Bincludes a distal end 420, a proximal end 425, a proximal cylindricalopening 430 of a cylindrical bore 432, and a distal cylindrical opening437 of the bore 432. The cylindrical bore 432 extends the full length ofthe implant arm outer portion 110B between the proximal opening 435 andthe distal opening 437. Longitudinally extending grooves 440 areradially distributed about the inner circumferential surface of the bore432 in an arrangement that matches the longitudinal raised ribs 405 ofthe implant arm inner portion 110A such that the ribs 405 are receivedin the grooves 440 in a mated arrangement when the inner portion 110A isreceived in the bore 432 of the outer portion 110B. The anchor arm 115extends off the implant arm outer portion 110B at an angle as describedabove with respect to the previously discussed embodiments. The anchorarm 115 terminates at its free end in a collar 165 similar to thosealready discussed above.

As shown in FIGS. 87 and 88, the implant retainer 95 includes a proximalend 215, a distal end 220, and a lumen 445 extending the full length ofthe implant retainer 95. The proximal end 215 includes a squared,pentagonal or hexagonal outer surface configuration 450 that facilitatesa mechanical engagement arrangement with the handle 90 such as themechanical arrangement that exists between a wrench and nut. A ring 451radial extends from the retainer 95 at the distal edge of the squared,pentagonal or hexagonal configuration 450. The distal end 220 may bethreaded or otherwise configured to engage a proximal end of anyone ofthe implants 25 disclosed herein.

As illustrated in FIGS. 87 and 88, the collar assembly 400 includes ahelical spring 455, rings 460A and 460B, washer 460C, retainer balls461, and a retaining collar 465. As shown in FIG. 89, which is anisometric view of the handle 90, a cylindrical neck portion 470 of thehandle 90 includes a shoulder 476 which slopes down to a circumferentialgroove 475 and a pair of holes 480 defined in the outer circumferentialsurface of the neck 470.

As indicated in FIG. 90, which is an exploded isometric view of theretaining collar 465 and handle 90 shown in longitudinal cross section,the holes 480 extend through the cylindrical wall 485 that defines theneck 470 and a cylindrical void 487 within the neck. A squared,pentagonal or hexagonal inner surface configuration 490 is defined inthe handle 90 distal the cylindrical void 487 to receive in a matingarrangement the complementarily shaped outer configuration 450 of theproximal end of the implant retainer 95. A lumen 495 extends from aproximal end of the handle to open into the squared, pentagonal orhexagonal inner surface configuration 490.

As shown in FIG. 90, the retaining collar 465 includes a proximal end500, a distal end 505, an outer circumferential surface 510 and an innercircumferential surface 515 that defines the hollow interior of thecollar 517. The outer circumferential surface 510 extends radiallyoutward to form a rim 520 near the proximal end 500. The innercircumferential surface 515 has a stepped and ramped configuration.Specifically, working distal to proximal, the inner circumferentialsurface 515 includes a proximal inner ring 525 separated from anintermediate inner ring 530 by a proximal large diameter region 535separated from a small diameter region 540 by a ramped surface 545.Proximal the intermediate inner ring 530 is another large diameterregion 550 bordered on its proximal boundary by a groove 555.

As can be understood from FIG. 91, which is a longitudinal cross sectionof the delivery tool 20 when assembled as shown in FIG. 86, the implantarm inner portion 110A is received in the implant arm outer portion 110Bsuch that the ribs 405 are matingly received in the corresponding slots440 and the ring 410 abuts against the distal end 420 of the outerportion 110B. The implant retainer 95 extends through the inner portion110A such that the distal end 220 of the implant retainer distallyextends from the distal end 120 of the inner portion 110A and the ring451 abuts against the proximal end 125 of the inner portion 110A. Theproximal ends of the inner portion 110A and retainer 95 are received inthe volume 487 (see FIG. 90) of the neck 470, the squared, pentagonal,or hexagonal portion 450 of the retainer 95 matingly received in thecomplementarily shaped volume 490 of the neck such that the ring 451abuts against the step in the neck between the volume 490 of the neckand the rest of the volume of the neck distal thereto. The distal end ofthe neck 470 abuts against the proximal end 425 of the outer portion110B.

As illustrated in FIG. 91, a first lock ring 460A is received in thegroove 555 in the collar 465. A second lock ring 460B is received in thecircumferential groove 475. A washer 460C is received on the neck 470and abuts shoulder 476, which prevents washer 460C from advancingproximally beyond shoulder 476, and washer 460C is held in placedistally by second lock ring 460B. Helical spring 455 circumferentiallyextends about the neck 470 between the washer 460C and the intermediateinner ring 530 of the collar 465. Thus, the spring biases the collar 465distally on the neck 470. First lock ring 460A prevents collar 465 fromdistal disengagement from neck 470; the ring 460A, due to the forcesexerted by a compressed spring 455 abuts washer 460C under normalconditions until manipulation by a medical person acting to move collar465 proximally which in turn moves first lock ring 460A proximallythereby creating a further distance between first lock ring 460A andwasher 460C.

As depicted in FIG. 91, neck holes 480 can be configured to have asufficient diameter to allow the retaining balls 461 to enter from theopening nearest the outer circumferential surface of the neck 470 and tobe seated within holes 480, the configuration further allowing a portionof the retaining balls 461 to extend into the cylindrical void 487 suchto allow sufficient engagement with groove 415 as further describedbelow. The neck holes 480 can be further configured, as depicted in FIG.91, to have a slight reduction in their diameter, the reduction ofdiameter occupying a small portion of the holes 480 nearest thecylindrical void 487, thereby allowing for a configuration between neck470, neck holes 480 and retaining balls 461 such that the retainingballs 461 are resistant to completely entering cylindrical void 487after the removal of inner portion of the implant retainer 95 andimplant arm inner portion 110A. The balls 461 are each held in theirrespective holes 480 in the neck 470 by the balls 461 being trappedbetween the neck holes 480 and inner circumferential surface of thecollar 465. Therefore, when the collar 465 is biased distally on theneck, the balls 461 are inwardly forced by the reduced diameter region540 to lock into the groove 415 of the inner portion 110A, retaining theproximal end of the anchor arm 110 in the handle/collar assembly. Whenthe collar 465 is pulled proximally by a medical person using the tool20, the balls 461 are exposed to the large diameter region 535, allowingthe balls 461 sufficient play to radially outwardly move in the holes480 to allow the balls to escape the groove 415, thereby allowing theproximal end of the anchor arm 110 to be removed from the handle/collarassembly.

As shown in FIG. 91, the lumens 495 and 445 are aligned to make onecontinuous lumen through the assembled tool 20. Thus, the tool 20 can befed over a guidewire, stylet, needle or etc., or such implements can befed through the lumen. Also, a bone paste, in situ curable biocompatiblematerial, or similar material can be fed through the lumen to an implant25 positioned in the joint via the tool.

As can be understood from FIGS. 86-91, the collar assembly 400 retainsthe proximal end of the implant arm 110 in the neck of the handle 90.The collar assembly 400 can be displaced proximally on the neck of thehandle 90 to allow the proximal end of the implant arm 110 to be removedfrom the neck of the handle. When the implant arm 110 is coupled to thehandle 90, the portions 110A and 110B of the implant arm 110 are lockedtogether and prevented from displacing relative to each other, but thehandle 90 and retainer 95 can be caused to rotate as a unit relative tothe implant arm 110 to cause the distal end 220 of the retainer 95engage or disengage the implant 25 as desired. Accordingly, theconfiguration allows for the removal of a handle 90 during the course ofa procedure while allowing the retainer 95 to maintain engagement withimplant 25 as desired.

Additionally, as a non-limiting example, according to particularembodiments, a reversible locking ratcheting mechanism can be employedto prevent undesired rotation of the handle and other components whichcould loosen the connection between implant 25 and retainer 95.

As illustrated in FIG. 92, which is a side view of an implant retainer95 similar to that described with respect to FIGS. 86-91, except havinga modified distal end 220. Specifically, the embodiment of FIG. 92 hasT-shaped distal end 220. In one embodiment, the T-shaped distal end 220includes a cylindrical center portion 220A and ears or tabs 220Boppositely positioned on the center portion 220A from each other.

FIGS. 93-94 are, respectively, longitudinal and transverse crosssectional views of an implant 25 with an engagement hole 70 configuredto complementarily engage with the T-shaped distal end 220 of theretainer 95 of FIG. 92. As illustrated in FIGS. 93-94, the hole 70includes a cylindrical longitudinally extending center portion 70A withlongitudinally extending grooves 70B located oppositely from each other.Inner radially extending grooves 70C intersect the distal ends of thegrooves 70B.

As shown in FIG. 95, which is the same view as FIG. 93, except with theretainer 95 received in the hole 70, the cylindrical retainer portion220A is received in the cylindrical hole portion 70A, and the retainertab portions 220B are received in the hole grooves 70B. Once the distalend 220 of the retainer 95 is sufficiently received in the hole 70 suchthat the retainer tab portions 220B are aligned with the associatedradially extending grooves 70C as illustrated in FIG. 95, the retainer95 can be rotated within the hole 70 to cause the tab portions 220B tomove into the radially extending grooves 70C, thereby locking the distalend 220 of the retainer 95 in the hole 70 of the implant 25. Grooves 70Ccan be configured such as to form an interference fit, therebypreventing retainer 95 from being separated from the implant 25 withoutthe intentional application of substantial rotational separating force.Reversing the rotation of the retainer can cause the tab portions 220Bto exit the radial grooves 70C, thereby unlocking the retainer distalend from the implant hole. Alternatively, according to particularembodiments, as a non-limiting example, radially extending grooves 70Ccan be configured to have at least one ramped surface, which uponrotation of retainer 95 into the grooves 70C, urges the distal end 220 adistance further in the direction of distal end 42 of implant 25 therebycreating increased friction between ring 45 of retainer 95 and proximalend 125 of 110A thereby preventing undesirable reverse rotation of theretainer without the intentional application of substantial rotationalseparating force, which otherwise could lead to an unlocking of theretainer distal end from the implant hole.

As illustrated in FIG. 93, in one embodiment, the implant 25 may includea lumen 600 extending the length of the implant through the anchor hole40 and the retainer engagement hole 70. Such a lumen 600 may serve toreceive a guidewire or stylet there through. Such a lumen 600 may serveto receive an injection of bone paste material, or other biocompatiblematerial.

To begin a detailed discussion of a fourth embodiment of the system 10,reference is made to FIGS. 109 and 110. FIG. 109 is an isometric view ofthe system 10 wherein the tool 20 is attached to the implant 25 fordelivery of the implant to the sacroiliac joint. FIG. 110 is a view ofthe system 10 wherein the implant 25 and anchor arm 115 are shown inplan view.

As can be understood from FIGS. 109-110, the system 10 includes adelivery tool 20 and an implant 25 for implanting at the sacroiliacjoint via the delivery tool 20, the implant 25 being for fusing thesacroiliac joint. As can be understood from a comparison of FIGS. 109and 86, the tool embodiment of FIG. 109 is substantially similar to thetool embodiment of FIG. 86, except the tool embodiment of FIG. 109 hasan anchor arm 115 that distally ends in multiple anchor collars 165a-165 d.

As can be understood from a comparison of FIGS. 109 and 7, the implantembodiment of FIG. 109 is substantially similar to the implantembodiment of FIG. 7, except the implant embodiment of FIG. 109 hasmultiple bores 40 a-40 b.

As illustrated in FIGS. 109-110, the anchor collars 165 may include twolinearly aligned center collars 165 a and 165 b, and a lateral anchorcollar 165 c and 165 d may be located on either side of the mostproximal center collar 165 b. As indicated in FIG. 110, the two centercollars 165 a and 165 b may be axially aligned with the respective bores40 a and 40 b of the implant 25 when the implant 25 is supported off ofthe distal end of the implant arm 110 of the tool 20. As a result, ananchor member 30 (see, for example, FIG. 4) may be delivered into eachof the bores 40 a and 40 b via the respective anchor collars 165 a and165 b. The lateral anchor collars 165 c and 165 d may be employed todeliver yet additional anchor members 30 to additional anchor memberreceiving features (e.g., bores, etc.) existing on, or extending fromthe sides of, the implant 25, where such additional anchor memberreceiving features are present on the implant 25. Alternatively, lateralcollars 165 c and 165 d can be configured to deliver additional anchormembers 30 into the bone of the ilium and sacrum while not passingthrough a bore 40 (i.e., preconfigured to place anchor members 30immediately adjacent the longitudinal side edges of the implant 25.

To begin a discussion regarding the methodology associated withemploying any of the above-described delivery tools 20 in implanting anyof the above-described implants 25 in the sacroiliac joint 1000 of apatient 1001, reference is first made to FIGS. 96A-98B to identify thebone landmarks adjacent, and defining, the sacroiliac joint 1000. FIG.96A is a right lateral side view of a hip region 1002 of a patient 1001lying prone, wherein the soft tissue 1003 surrounding the skeletalstructure 1006 of the patient 1001 is shown in dashed lines. FIG. 96B isan enlarged view of the hip region 1002 of FIG. 96A. As illustrated inFIGS. 96A and 96B, a lateral view of the patient's hip region 1002reveals certain features of the ilium 1005, including the anteriorsuperior iliac spine 2000, the iliac crest 2002, the posterior superioriliac spine 2004, the posterior inferior iliac spine 2006, the greatersciatic notch 2008 extending from the posterior inferior iliac spine2006 to the ischial spine 2010, and the tubercle of iliac crest 2012.The sacroiliac joint articular region 1044 is shown in dashed lines. Aposterior inferior access region 2016 of the sacroiliac joint articularregion 1044 has a superior end 2018 on the sacroiliac joint line 2019that is between approximately 0 mm and approximately 40 mm inferior theposterior inferior overhang 2020 of the posterior superior iliac spine2004. The posterior inferior access region 2016 of the sacroiliac jointarticular region 1044 has an inferior end 2022 on the sacroiliac jointline that is at approximately the intersection of the posterior inferioriliac spine 2006 with the lateral anterior curved boundary 2024 of thesacrum 1004. In other words, the posterior inferior access region 2016of the sacroiliac joint articular region 1044 has an inferior end 2022on the sacroiliac joint line that is at approximately the superiorbeginning of the greater sciatic notch 2008.

FIG. 97A is a lateral-posterior view of the hip region 1002 of thepatient 1001 of FIG. 96A, wherein the patient 1001 is lying prone andthe soft tissue 1003 surrounding the skeletal structure 1006 of thepatient 1001 is shown in dashed lines. FIG. 97B is an enlarged view ofthe hip region 1002 of FIG. 97A. As shown in FIGS. 97A and 97B, alateral-posterior view of the patient's hip region 1002 reveals the samefeatures of the sacrum 1004 and ilium 1005 as discussed above withrespect to FIGS. 96A and 96B, except from another vantage point. Thevantage point provided via FIGS. 97A and 97B provides furtherunderstanding regarding the posterior inferior access region 2016 of thesacroiliac joint articular region 1044 and superior end 2018 andinferior end 2022 of the posterior inferior access region 2016 relativeto nearby anatomical features, such as, for example, the posteriorinferior overhang 2020 of the posterior superior iliac spine 2004, theintersection of the posterior inferior iliac spine 2006 with the lateralanterior curved boundary 2024 of the sacrum 1004, and the superiorbeginning of the greater sciatic notch 2008.

FIG. 98A is a posterior view of the hip region 1002 of the patient 1001of FIG. 96A, wherein the patient 1001 is lying prone and the soft tissue1003 surrounding the skeletal structure 1006 of the patient 1001 isshown in dashed lines. FIG. 98B is, an enlarged view of the hip region1002 of FIG. 98A. As shown in FIGS. 98A and 98B, a posterior view of thepatient's hip region 1002 reveals the same features of the sacrum 1004and ilium 1005 as discussed above with respect to FIGS. 96A and 96B,except from yet another vantage point. The vantage point provided viaFIGS. 98A and 98B provides yet further understanding regarding theposterior inferior access region 2016 of the sacroiliac joint articularregion 1044 and superior end 2018 and inferior end 2022 of the posteriorinferior access region 2016 relative to nearby anatomical features, suchas, for example, the posterior inferior overhang 2020 of the posteriorsuperior iliac spine 2004, the intersection of the posterior inferioriliac spine 2006 with the lateral anterior curved boundary 2024 of thesacrum 1004, and the superior beginning of the greater sciatic notch2008.

Now that the relevant anatomical landmarks have been identified withrespect to FIGS. 96A-98B, the methodology associated with employing anyof the above-described delivery tools 20 in implanting any of theabove-described implants 25 in the sacroiliac joint 1000 of a patient1001 can be discussed. In doing so, reference will be made to FIGS.99A-99P, which are each a step in the methodology and illustrated as thesame transverse cross section taken in along a plane extendingmedial-lateral and anterior posterior along section line 99-99 in FIG.98B. In this cross section, articular surfaces 1016 are covered by athick layer of articular cartilage with a joint space existing betweenthem, the FIGS. 99A-99P are simplified for illustrative purposes and donot show these features to scale. Now referring primarily to FIG. 99A,an embodiment of the method can include the step of placing a patientunder sedation prone on a translucent operating table (or other suitablesurface). The sacroiliac joint 1000 can be locally anesthetized to allowfor injecting a radiographic contrast 1046 (as a non-limiting example,Isoview 300 radiographic contrast) under fluoroscopic guidance into theinferior aspect of the sacroiliac joint 1000 to outline the articularsurfaces 1016 of the sacroiliac joint 1000) defined between the sacrum1004 and ilium 1005, the sacroiliac joint 1000 having an interarticularregion 1044. Injection of the radiographic contrast 1046 within thesacroiliac joint 1000 can be accomplished utilizing a tubular member1047) (such as a syringe needle) having first tubular member end 1048which can be advanced between the articulating surfaces 1016 of thesacroiliac joint 1000 and having a second tubular member end 1049 whichremovably couples to a hub 1050. The hub 1050 can be configured toremovably couple to a syringe barrel 1051 (or other device to containand deliver an amount of radiographic contrast 1046). In the example ofa syringe barrel 1051, the syringe barrel 1051 can have an internalvolume capable of receiving an amount of the radiographic contrast 1046sufficient for outlining the articular surfaces 1016 of the sacroiliacjoint 1000, for example, under lateral fluoroscopy. A plunger 1052 canbe slidingly received within the barrel 1051 to deliver the radiographiccontrast 1046 through the tubular member 1047 into the sacroiliac joint1000. The tubular member 1047 can have a gauge in the range of about 16gauge and about 20 gauge and can further be incrementally marked on theexternal surface to allow determination of the depth at which the firstneedle end 1048 has advanced within the sacroiliac joint 1000. As thefirst needle end 1048 advances into the sacroiliac joint 1000 theradiographic dye 1046 can be delivered from within the syringe barrel1051 into the sacroiliac joint 1000 to allow visualization of thesacroiliac joint 1000 and location of the tubular needle 1047 within thesacroiliac joint 1000.

Now referring primarily to FIG. 99B, once the first tubular member end1048 has been sufficiently advanced into the sacroiliac joint 1000 andthe articular surfaces 1016 of the sacroiliac joint 1000 have beensufficiently visualized, the hub 1050 can be removed from the tubularmember 1047 leaving the tubular member 1047 fixed within the sacroiliacjoint 1000 as an initial guide for tools subsequently used to locate orplace the sacroiliac joint implant 25 non-transversely between thearticulating surfaces 1016 of the sacroiliac joint 1000 (e.g., locatethe implant 25 non-transversely to the joint plane 1030 generallydefined by the articulating surfaces 1016 of the interarticular region1044 of the sacroiliac joint 1000) or in removal of a portion of thesacroiliac joint 1000 within the region defined by the articularsurfaces 1016 to generate an implant receiving space 1029 (see FIG.99H). Alternately, one or more guide pins 1013 can be inserted alongsubstantially the same path of the tubular member 1047 for fixedengagement within the sacroiliac joint 1000 and used in subsequent stepsas a guide(s).

Now referring primarily to FIG. 99C, a small incision 1053 can be madein the skin at the posterior superior (or as to certain embodimentsinferior) aspect of the sacroiliac joint 1000, extending proximal anddistal to the tubular member 1047 along the line of the sacroiliac joint1000 to provide a passage to access the interarticular space between thearticulating surfaces 1016 (see FIG. 99B) of the sacroiliac joint 1000.More specifically, as can be understood from FIGS. 96A-98B, in oneembodiment, the small incision 1053 can be made along the joint line2019 of the sacroiliac joint 1000 in the tissue covering the posteriorinferior access region 2016 of the sacroiliac joint articular region1044. A cannulated probe 1054 can be slidingly engaged with the tubularmember 1047 (or guide pin 1013) extending outwardly from the sacroiliacjoint 1000 (while the sacroiliac joint may be shown in the figures asbeing substantially linear for illustrative purposes, it is to beunderstood that the normal irregular features of the sacroiliac jointhave not been removed). The cannulated probe 1054 can have a probe body1054 of generally cylindrical shape terminating in a spatulate tip 1055at the end advanced into the sacroiliac joint 1000. A removablecannulated probe handle 1056 couples to the opposed end of the probebody 1054. The spatulate tip 1055 can be guided along the tubular needle1047 or guide wire 1013 into the posterior portion of the sacroiliacjoint 1000 and advanced to the anterior portion of the sacroiliac joint1000 under lateral fluoroscopic visualization. The cannulated probehandle 1056 can then be removed providing the generally cylindricalprobe body 1054 extending outwardly from the sacroiliac joint 1000through the incision 1053 made in the skin.

Alternatively, probe 1054 can be used to guide, advance or place aneedle, guide wire or other instrument up to, near, or into the joint.

Additionally, in particular embodiments, probe handle 1056 or theopposed end of the probe body 1054, or both, can be configured to havean interference fit or a luer lock hub to communicate with a syringebarrel 1051 in order to advance contrast, in situ curable biocompatiblematerials, stem cells, or etc. through the cannulated probe 1054 orcannulated probe handle 1056.

Now referring primarily to FIG. 99D, a passage from the incision 1053(see FIG. 99C) to the sacroiliac joint 1000 can be generated byinserting a cannula 1057 into the incision. A soft tissue dilator 1058having a blunt end 1059 can be advanced over the probe body 1054, or aplurality of soft tissue dilators of increasing size, until the bluntend 1059 of the soft tissue dilator 1058 and the corresponding cannulaend contact the posterior aspect of the sacroiliac joint 1000. Morespecifically, as can be understood from FIGS. 96A-98B, in oneembodiment, the ends of the dilator 1058 and cannula 1057 contact thejoint line 2019 of the sacroiliac joint 1000 at the posterior inferioraccess region 2016 of the sacroiliac joint articular region 1044. Thesoft tissue dilator 1058 can be removed from within the cannula 1057.The external surface of the cannula 1057 can be sufficiently engagedwith the surrounding tissue to avoid having the tissue locate with inthe hollow inside of the cannula 1057. A non-limiting embodiment of thecannula 1057 provides a tubular body having substantially parallelopposed side walls which terminate in a radius at both ends (lozengeshape) into which a plurality of different jigs can be inserted.Alternatively, as a non-limiting example, according to particularembodiments, cannula 1057 and corresponding dilators 1058 and alignmentjigs 1060 can be configured to have tubular bodies with an elliptical orcircular cross section.

In some embodiments, the cannula 1057 may be additionally configured tohave within or near its walls a light source such as, for example, afiber optic or a LED light source to assist in visualization of theworking area. Also, in some embodiments, irrigation and suction tubingmay communicate with the inside passage of cannula 1057.

Now referring primarily to FIGS. 100A-100C, a cannula alignment jig 1060can be advanced over the probe body 1054 (or guide pins 1013) andreceived within the cannula 1057. Substantially, identical cross hairs1063, 1064 can be disposed on the upper jig surface 1065 and the lowerjig surface 1066. Alignment of the cross hairs 1063, 1064 under x-raywith the sacroiliac joint 1000 can confirm that the cannula 1057 hasproper orientation in relation to the paired articular surfaces 1016 ofthe sacroiliac joint 1000. The cannula 1057 properly oriented with thepaired articular surfaces 1016 can then be disposed in fixed relation tothe sacroiliac joint by placement of fasteners through the cannula 1057into the sacrum 1004 or the ilium 1005.

Now referring to FIGS. 101A and 101B, a first drill jig 1067 can beadvanced over the probe body 1054 (or guide pins 1013) and receivedwithin the cannula 1057. The probe body 1054 (or guide pins 1013)extending outwardly from the sacroiliac joint 1000 passes through adrill guide hole 1068 of the first drill jig 1067 (or a plurality ofguide pins 1013 can extend through a corresponding plurality of guidepin holes 1069). The drill guide hole 1068 can take the form of acircular hole as shown in the Figures, a slot, or other configuration torestrict the movement of the drill bit 1062 (see FIG. 99E) within thedrill jig 1060 and provide a guide for a drill bit 1062 in relation tothe sacroiliac joint 1000. Guide pin holes 1069 can receive guide pinswhich can be positioned between the articular surfaces 1016 of thesacroiliac joint 1000 to demarcate the zone of desired treatment or safeworking zones while using, for example, lateral fluoroscopy. As anon-limiting example, a first guide pin 1013 can be advanced through afirst guide pin hole 1069, or alternatively a guide pin 1013 is firstinserted into the sacroiliac joint 1000 and subsequently a guide jig1067 is advanced over the guide pin 1013, the first guide pin 1013 canenter near inferior end 2022 of the posterior inferior access region2016 of the sacroiliac joint articular region 1044 via the sacroiliacjoint line 2019 to border a portion of the greater sciatic notch 2008thereby allowing a medical person, computer guided surgical system, orother observer to more easily highlight under x-ray a border whichshould not be crossed during the procedure due to the presence of nerveand other structures. Additionally, as a non-limiting example, firstguide pin 1013 can configured as an electrode, insulated from theoperator and the patient's soft tissues, and may be connected to amonitor to signal to an operator or surgeon when implant 25, configuredwith a stimulating electrode (NM), as discussed below, comes intocontact with first guide pin. Similarly, a second guide pin 1013 can beplaced in another guide pin hole 1069 to demarcate a second limit to adesired zone of treatment, or safe working zone. For example, a secondguide pin 1013 can enter near the superior end 2018 of the posteriorinferior access region 2016 of the sacroiliac joint articular region1044 via the sacroiliac joint line 2019 to be positioned to border anarea of the sacroiliac joint 1000 such as a transition zone between theextra-articular 3007 (see FIG. 106B) and the interarticular region 1044which, for example, has been highlighted by contrast material as abovedescribed.

Now referring to FIG. 99E, a cannulated drill bit 1070 can be advancedover the probe body 1054 and within a drill guide hole 1068 (see FIGS.101A and 101B) of the first drill jig 1067. The cannulated drill bit1070 under fluoroscopic guidance can be advanced into the interarticularregion 1044 between the articulating surfaces 1016 of the sacroiliacjoint 1000 to produce a first bore 1071 (shown in broken line) to adetermined depth. As to certain embodiments of the method, an amount ofarticular cartilage or other tissues from between the articular surfaces1016 of the sacroiliac joint 1000 can be removed sufficient to allowembodiments of the sacroiliac joint implant 25 to be implanted inreplacement of the removed articular cartilage or tissue. Because themethod removes the degenerative articular cartilage or tissue betweenthe articular surfaces 1016 of the sacroiliac joint 1000, the articularsurfaces 1016 of the sacroiliac joint 1000 can remain intact orsubstantially intact allowing the sacroiliac joint implant 25 to benon-transversely located between the articular surfaces 1016 of thesacroiliac joint 1000. Understandably, other instruments can be utilizedseparately or in combination with a cannulated drill bit 1062 for theremoval of articular cartilage or tissue between articular surfaces 1016such as: endoscopy tools, box chisels, side cutting router bits, burs,flexible burs and bits, hole saws, curettes, lasers (such as C02,Neodymium/YAG (yttrium-aluminum-garnet), argon, and ruby),electrosurgical equipment employing electromagnetic energy (the cuttingelectrode can be a fine micro-needle, a lancet, a knife, a wire or bandloop, a snare, an energized scalpel, or the like) where the energytransmitted can be either monopolar or bipolar and operate with highfrequency currents, for example, in the range of about 300 kHz and about1000 kHz whether as pure sinusoidal current waveform where the “crestfactor” can be constant at about 1.4 for every sinus waveform, and avoltage peak of approximately 300 V to enable a “pure” cutting effectwith the smallest possible coagulation effect or as amplitude modulatedcurrent waveforms where the crest factor varies between 1.5 and 8, withdecreasing crest factors providing less of a coagulation effect.Electrosurgical waveforms may be set to promote two types of tissueeffects, namely coagulation (temperature rises within cells, which thendehydrate and shrink) or cut (heating of cellular water occurs sorapidly that cells burst). The proportion of cells coagulated to thosecut can be varied, resulting in a “blended” or “mixed” effect.Additionally, a fully rectified current, or a partially rectifiedcurrent, or a fulguration current where a greater amount or lateral heatis produced can be employed to find the articular surfaces of the jointand aid in advancing a probe or guide wire into a position in betweenthe articulating surfaces. These currents can effectively degrade thecartilage and allow advance into the joint without grossly penetratingmuch beyond the cartilage.

Now referring to FIG. 99F, as to certain embodiments of the invention,the first drill jig 1067 can be removed from within the cannula 1057 anda second drill jig 1072 can be advanced over the probe body 1054 andreceived within the cannula 1057; however, the invention is not limitedto any particular number of drill jigs and as to certain embodiments ofthe method the first drill jig 1067 can include all the required drillguide hole(s) 1068 (or slots or other configurations of the drill guide)and as to other embodiments of the method a plurality of drill jigs canbe utilized in serial order to provide all the drill guide holes 1068.As to the particular embodiment of the invention shown by the Figures,the first drill jig 1067 can provide one or more additional drill guideholes 1068 which guide in relation to the first bore 1071 a second ormore cannulated drills 1062 of the same or different configuration to beinserted within and advanced into the sacroiliac joint 1000 to produce asecond bore 1073 (generally shown in broken line as 1071/1073) or aplurality of bores within the sacroiliac joint 1000 spaced apart inpredetermined pattern to allow removal of sufficient articular cartilage1016 or other tissue from the interarticular space of sacroiliac joint1000 for placement of embodiments of the sacroiliac joint implant 25within the region defined by and between the paired articular surfaces1016 of the sacroiliac joint 1000. As to certain methods of theinvention, the first drill jig 1067 or the second drill jig 1072 or aplurality of drill jigs can be utilized in serial order to remove aportion of the sacroiliac joint 1000 for generation of an implantreceiving space 1029 (see, for example, FIG. 99H). As these embodimentsof the method, articular cartilage or other tissues and sufficientsubchondral bone can be removed from between the articular surfaces 1016of the sacroiliac joint 1000 sufficient to allow placement of certainembodiments of the sacroiliac joint implant 25 and one or more radialmember receiving channels 1074 can be cut into at least one of thearticular surfaces 1016 of said sacroiliac joint 1000 sufficient toreceive other embodiments of the sacroiliac implant 25. The one or moreradial member receiving channels 1074 can be cut a depth into thesubchondral, cortical bone or cancellous bone of the sacrum 1004 orilium 1005.

Now referring primarily to FIG. 99G in a subsequent step, the last inthe serial presentation of drill jigs 1067, 1072 can be removed fromwithin the cannula 1057 and a broach jig 1075 can be advanced over theprobe body 1054 to locate within the cannula 1057. The broach jig 1075can include a broach guide hole 1076 which receives a first broach end1077 of a cannulated broach 1078 advanced over the probe body 1054. Thefirst broach end 1077 can have a configuration which can be advancedinto the sacroiliac joint 1000. As to certain embodiments of the method,the first broach end 1077 can be adapted to remove an amount ofarticular cartilage and other tissue from between the articular surfaces1016 within the articular region 1044 of the sacroiliac joint 1000 fornon-transverse placement of a sacroiliac joint implant 25 having anelongate body 45, or having an elongate body 45 and a first radialmember 50, or an elongate body 45 having a first and second radialmembers 50 between the articular surfaces 1016 of the sacroiliac joint1000. As to other embodiments of the method, the cannulated broach 1078can remove a sufficient portion of the sacroiliac joint 1000 to generatean implant receiving space 1029 to receive embodiments of the sacroiliacjoint implant 25 having an elongate body 45, an elongate body 45 and atleast one radial member 50 adapted for non-transverse placement betweenthe articular surfaces 1016 or at least one radial member 55 adapted toextend into the bone of the sacrum 1004 or the ilium 1005.

As a non-limiting example, FIG. 99G shows a broach 1078 configured toremove a portion of the sacroiliac joint 1000 to produce an implantreceiving space 1029 (shown in FIG. 99H) to receive embodiments of thesacroiliac joint implant 25 having an elongate body 45 to which a firstradial member 50 and a second radial member 50 extend along thelongitudinal axis CA of the elongate body 45 in substantially opposedrelation adapted to locate between the articular surfaces 1016 of thesacroiliac joint 1000 and further having a third radial member 55 and afourth radial member 55 which extend along the longitudinal axis CA ofthe elongate body 45 in substantially opposed relation adapted tocorrespondingly extend correspondingly into the bone of the sacrum 1004and the ilium 1005.

Now referring primarily to FIGS. 102A-102D, the implant receiving space1029 and the sacroiliac joint implant 25 can be configured havingrelated dimension relations such that placement of the sacroiliac jointimplant 25 within the implant receiving space 1029 disposes the sacrum1004 and the ilium 1005 in substantially immobilized relation andsubstantially avoids alteration of the positional relation of the sacrum1004 and the ilium 1005 from the normal condition, or avoids drivingtogether or driving apart the sacrum 1004 from the ilium 1005 outside ofor substantially outside of the normal positional relation. An intentionin selecting configurations of the sacroiliac joint implant 25 and theimplant receiving space 1029 being immobilization of the sacrum 1004 inrelation to the ilium 1005 while maintaining the sacroiliac joint 1000in substantially normal or substantially normal positional relation, orreturning the sacroiliac joint 1000 to a substantially normal positionalrelation to correct a degenerative condition of the sacroiliac joint1000.

As a non-limiting example, configurations of an implant receiving space1029 allow embodiments of the sacroiliac joint implant 25 to be placednon-transversely between the caudal portion 1086 of the articularsurfaces 1016 of the sacroiliac joint 1000. While certain embodiments ofthe sacroiliac joint implant 25 may only provide an elongate body 45which locates within a correspondingly configured implant receivingspace 1029 to engage at least a portion of the bone of the ilium 1005 orsacrum 1004, the invention is not so limited, and can further include atleast a first radial member or a first and a second radial member atleast a portion of the external surface of the first radial member 50engaging a portion of the bone 1073 of the sacrum 1004 and the ilium1005. As to those embodiments of the sacroiliac joint implant 25 whichhave a third radial member 55 and a fourth radial member 55, the implantreceiving space 1029 can further include one or more radial memberreceiving channels 1074, which correspondingly allow the third andfourth radial members 55, 55 to extend into the bone 1073 of the sacrum1004 or the ilium 1005 (whether subchondral, cortical, cancellous, orthe like), or impact of the sacroiliac joint implant 25 into the implantreceiving space 1029 without the radial member receiving channels 1074can forcibly urge the radial members 55, 55 into the bone 1073 of thesacrum 1004 and the ilium 1005. An anchor member 30 (such as treadedmembers) can be inserted through the bore 40 in the implant 25 and intothe sacrum 1004 and ilium 1005 to fix the location of the fixationfusion implant 25 within the implant receiving space 1029.

While the preceding discussion is given in the context of the implant 25being implanted non-transversely in the caudal portion 1086 of thesacroiliac joint 1000, in other embodiments, the implant 25 may beimplanted in other locations within the sacroiliac joint. For example,as disclosed in U.S. patent application Ser. No. 12/998,712, now U.S.Pat. No. 8,979,928, which is incorporated herein by reference, in someembodiments, the implant 25 may be implanted non-transversely in thecranial portion 1087 (see FIG. 102A) of the sacroiliac joint 1000 by thesimilar procedures or steps as above described with the incision andgeneration of the passage to the superior articular portion of thesacroiliac joint 1000. The implant may also be implanted in thesacroiliac joint in such a manner so as to extend between the cranialand caudal portions, as also disclosed in U.S. patent application Ser.No. 12/998,712, now U.S. Pat. No. 8,979,928.

To begin a discussion of employing the delivery tool 20 to implant theimplant 25 in the sacroiliac joint 1000 once the implant receiving space1029 has been created, reference is made to FIGS. 99I, 103A, 103B and104. FIG. 103A is generally the same view as FIG. 97A, and FIG. 103B isan enlarged view of the hip region of FIG. 103A. FIG. 104 is generallythe same enlarged view as FIG. 96B. As shown in FIGS. FIGS. 99I, 103A,103B and 104, once the implant receiving space 1029 has been created asdiscussed above with respect to FIGS. 99A-99H, the implant 25 can besupported off of the distal end 120 of the implant arm 110 of thedelivery tool 20 and positioned such that the distal end 42 of theimplant 25 begins to enter the sacroiliac joint articular region 1044via the posterior inferior access region 2016, which is described indetail above with respect to FIGS. 96A-98B. As can be understood fromFIGS. 103A-104, in entering the sacroiliac joint space, the implant 25is oriented such that its wide planar members 50 are oriented generallyparallel to, and aligned with, the sacroiliac joint line 2019 (i.e., thewide planar members 50 are generally located within the joint plane1030), and the implant's narrow planar members 55 are generallytransverse to the joint plane 1030 (see, e.g., FIGS. 102C and 102D). Thelongitudinal axis LCA₂ of the implant arm 110 of the delivery tool 20has a generally anterior trajectory that is located within the jointplane 1030. Alternatively, according to particular embodiments, as anon-limiting example, the longitudinal axis LCA₂ of the implant arm 110of the delivery tool 20 can have a trajectory which can be defined asbeing generally lateral or, in particular embodiments, generallyposterior. In some embodiments, when the implant 25 is being deliveredinto the joint space, the implant arm 110 can be said to be at least oneof generally superior or cephalad the sciatic notch.

FIG. 105 is the same view as FIG. 104, except the implant 25 has nowbeen fully inserted into the prepared space 1029 in the sacroiliac joint1000. As illustrated in FIGS. 99J and 105, the implant 25 is fullyreceived in the prepared sacroiliac space 1029 such that the wide planarmembers 50 are oriented generally parallel to, and aligned with, thesacroiliac joint line 2019 (i.e., the wide planar members 50 aregenerally located within the joint plane 1030), and the implant's narrowplanar members 55 are generally transverse to the joint plane 1030 and,in some embodiments, have even entered the bone material forming thesacrum and ilium articular surfaces of the sacroiliac joint (see, e.g.,FIGS. 102C and 102D). As can be understood from FIG. 99J, thelongitudinal axis of the implant 25 and the longitudinal axis of theimplant arm 110 may be coaxially aligned with each other and generallylocated in the sacroiliac joint plane 1030.

FIG. 106A is the same view as FIG. 104, except the sleeve 100 is nowreceived in the collar 165 of the anchor arm 115. As can be understoodfrom FIGS. 99K and 106A, the distal end of the sleeve 100 may extendthrough an incision in the patient's soft tissue such that the distalend of the sleeve 100 is positioned generally against the lateralsurface of the ilium 1005. The longitudinal axis of the sleeve andcollar of the anchor arm can be understood to be generally coaxiallyaligned with the longitudinal axis of the bore 40 of the implant 25.

FIG. 106B is generally the same view as FIG. 106A, except the ilium 1005is removed to show the sacroiliac joint space boundary 3000 definedalong the sacrum 1004 and outlining the sacroiliac joint articularregion 1044, the implant 25 positioned for implantation within thesacroiliac joint articular region 1044. As shown in FIG. 106B, thesacroiliac joint space boundary includes an inferior boundary segment3002, an anterior boundary segment 3004, a superior boundary segment3006, and a posterior boundary segment 3008. The inferior boundarysegment 3002 is immediately adjacent, and extends along, the sciaticnotch 2024.

The inferior boundary segment 3002 and anterior boundary segment 3004intersect to form an anterior-inferior corner 3010. The anteriorboundary segment 3004 and superior boundary segment 3006 intersect toform an anterior-superior corner 3012. The superior boundary segment3006 and posterior boundary segment 3008 intersect to form asuperior-posterior corner 3014. The posterior boundary segment 3008 andposterior inferior access region 2016 intersect to form asuperior-posterior corner 3016 of the posterior inferior access region2016. The inferior boundary segment 3002 and posterior inferior accessregion 2016 intersect to form an inferior-posterior corner 3018 of theposterior inferior access region 2016.

The inferior boundary segment 3002 extends between corners 3010 and3018. The anterior boundary segment 3004 extends between corners 3010and 3012. The superior boundary segment 3006 extends between corners3012 and 3014 and provides an access into the cranial portion 1087 ofthe sacroiliac joint. The posterior boundary segment 3008 extendsbetween corners 3014 and 3016. The posterior inferior access region 2016extends between corners 3016 and 3018 and provides an access into thecaudal region 1086 of the sacroiliac joint. The posterior boundarysegment 3008 separates articular region 1044 and extra-articular region3007, which includes the sacral fossa on the sacrum 1004 and thecorresponding iliac tuberosity on the ilium 1005 and defined by theextra-articular region boundary 3009.

As shown in FIG. 106B, the implant 25 is inserted via the implant arm110 of the delivery tool 20 into the caudal region 1086 of thesacroiliac joint articular region 1044. As shown via the implant 25 andimplant arm 110 shown in solid lines, in one embodiment, the implant 25enters the posterior inferior access region 2016, and is furtheradvanced into the caudal region 1086 of the sacroiliac joint articularregion 1044, in an orientation such that the implant arm 110 and wideplanar members 50 are in the joint plane 1030 (see, for example, FIGS.99I-99J) and the longitudinally extending edge 3050 of the wide planarmember 50 next to the inferior boundary segment 3002 is generallyparallel to, and immediately adjacent to, the inferior boundary segment3002. Thus, the distal end 42 of the implant is heading generallyperpendicular to, and towards, the anterior boundary segment 3004.

As shown in FIG. 106B via the implant 25 and implant arm 110 shown indashed lines, in one embodiment, the implant 25 enters the posteriorinferior access region 2016, and is further advanced into the caudalregion 1086 of the sacroiliac joint articular region 1044, in anorientation such that the implant arm 110 and wide planar members 50 arein the joint plane 1030 (see, for example, FIGS. 99I-99J) and thelongitudinally extending edge 3050 of the wide planar member 50 next tothe inferior boundary segment 3002 is somewhere between being generallyparallel to the inferior boundary segment 3002 (as illustrated by thesolid-lined implant 25 in FIG. 106B) or forming an angle AJ with theinferior boundary segment 3002 of up to approximately 50 degrees. Thus,the distal end 42 of the implant shown in dashed lines can be said tohead anywhere from generally perpendicular to, and towards, the anteriorboundary segment 3004 to heading generally towards the superior-anteriorcorner 3012, or points in between.

In one embodiment, the implant 25 may be first directed into the jointspace as illustrated by the solid-lined implant 25 in FIG. 106B afterwhich the implant 25 is rotated within the joint space to be positionedsomewhere between, and including, angled position depicted by thedashed-lined implant 25. In other embodiments, the implant 25 may befirst directed into the joint space as illustrated by the dashed-linedimplant 25 in FIG. 106B after which the implant 25 is rotated within thejoint space to be positioned somewhere between, and including, theparallel position depicted by the solid-lined implant 25.

FIG. 107A is a posterior-inferior view of the hip region 1002 of thepatient 1001, wherein the soft tissue 1003 surrounding the skeletal hipbones is shown in dashed lines. FIG. 107B is an enlarged view of theimplant region of FIG. 107A. As can be understood from FIGS. 99L, 107Aand 107B, the anchor member 30 is positioned in the lumen of the sleeve100. A driving tool 105 (e.g., screw driver) is extended through thelumen of the sleeve 100 so the distal end of the tool 105 is engagedwith a proximal end of the anchor member 30 (e.g., screw). As shown inFIG. 99M, the tool 105 is used to drive the anchor member 30 distallythrough the bone of the ilium 1005 and into the bore 40 of the implant25 generally transverse to the joint line plane 1030. As a result, asindicated in FIG. 99N, the implant assembly formed of the implant 25 andanchor member 30 is secured at the implantation site such that theimplant 25 is located in the prepared space 1029 of the sacroiliac jointspace, and the anchor member 30 extends through the bone of the ilium1005 and into the implant bore 40 generally transverse to the jointspace plane 1030. The tool 105 and sleeve 100 can be removed from theanchor arm collar 165, and the incision associated with the sleeve 100can be closed. Additionally, tool 105 can be a cutting tool 105 (e.g.,drill bit, hole punch, or etc.) which can used in similar steps as abovedescribe to remove bone or other tissues in the path where anchor member30 is to be placed.

As indicated in FIG. 99O, the distal end of the implant arm is decoupledfrom the proximal end of the implant 25 and removed. The incisionassociated with the implant arm can be closed. In some embodiments, theanchor member 30 will only be long enough to span bone of the ilium 1005and enter the implant bore 40. In other embodiments, as illustrated inFIG. 99P, the anchor member 30 will be sufficiently long to extendthrough the bone of the ilium, completely through the implant bore 40,and into the bone of the sacrum 1004. As illustrated in FIG. 99Q, incertain embodiments, implant 25 can be configured to have more than oneimplant bore 40 which can also receive an anchor member 30. The anchormember 30 prevents migration of the implant 25 within the joint space.The anchor member 30 also can draw the ilium and sacrum together aboutthe implant 25, increasing the sturdiness of the fixation of the implantin the joint space. Where the anchor member extends through the implantbore and into the bone of both the sacrum and ilium, the anchor member30 can be used to drawn the articular surfaces 1016 of the sacroiliacjoint 1000 against the external surfaces of the sacroiliac joint implant25. With the implant implanted in the sacroiliac joint, the body willcause the joint surfaces to fuse together about the implant 25.

As can be understood from FIGS. 108A and 108B, which are, respectively,posterior and posterior-lateral views the implantation area and theimplant assembly implanted there, proximal end 43 of the implant 25 canbe seen positioned in the posterior inferior access region 2016, theimplant being implanted in the caudal area of the sacroiliac jointspace. The anchor member 30 can be understood to have been driven intothe implant bore 40 transversely to the joint plane 1030 via a route inthe ilium 1005 that avoids contact with vascular and neurologicalstructures, thereby avoiding potentially life threatening injury to suchstructures. The ability to blindly, yet safely, drive the anchor member30 into the implant bore 40 while the implant 25 is hidden in the jointspace is made possible by the cooperating configurations of the implant25 and the delivery tool 20. Specifically, the longitudinal axis LCA₁ ofthe anchor arm collar 165 being coaxially aligned with the longitudinalaxis BA of the implant bore 40 when the proximal end 43 of the implant25 is supported off of the implant arm 115 of the delivery tool 20 makesit possible to safely drive the anchor member 30 through the ilium 1005bone and into the implant bore 40 when the implant is hidden in thejoint space on account of being delivered to the joint space via thedelivery tool 20.

To begin a detailed discussion of another method of employing the system10 to fuse the sacroiliac joint, reference is made to FIGS. 111A-111C.FIG. 111A is an inferior-posterior view of the patient's hip skeletalstructure similar to the view depicted in FIG. 107A. FIG. 111B is alateral-superior-posterior view of the patient's hip skeletal structure.FIG. 111C is an inferior-posterior view of the patient's hip skeletalstructure taken from a perspective laterally opposite the view depictedin FIG. 111B. The S1 through S4 foramina can be seen at the respectiveindicators S1, S2, S3 and S4 in FIGS. 111A-111C.

As can be understood from a comparison of FIGS. 111A to 107A, thedelivery tool 20 has been reversed such that the anchor collar 165 isoriented so as to deliver the anchor member 30 through the sacrum 1004first and then into the bore 40 of the implant 25 and optionally furtherinto the ilium 1005. In other words, unlike the method depicted in FIG.107A, wherein the anchor member 30 is driven lateral to medial throughthe ilium 1005 first and then into the implant followed by the sacrum1004 (optional), the method depicted in FIG. 111A shows the anchormember 30 being driven medial to lateral through the sacrum 1004 firstand then into the implant followed by the ilium 1005 (optional). As canbe understood from a comparison of FIGS. 111A to 107A, the implant 25 ofFIG. 111A is located in the sacroiliac joint with its wide radialmembers 50, narrow radial members 55 and body 45 oriented as explainedabove with respect to FIGS. 102A-107B, the only difference being thedirection the bore 40 is oriented and the way the anchor member 30penetrates the surrounding bone structures.

In the embodiment of FIG. 111A, the anchor member 30 may be an S2 alariliac (S2AI) screw. Such a screw may penetrate the sacrum 1004 justlateral the lateral edge of the S1 foramen and, in some instances,generally superiorly-inferiorly even with the superior edge of the S1foramen so as to mimic an S2 alar iliac pelvic fixation. Alternatively,according to particular embodiments, for example, as shown in FIG. 111A,such a screw may penetrate the sacrum 1004 just lateral the lateral edgeof the S2 foramen and, in some instances, generallysuperiorly-inferiorly even with the superior edge of the S2 foramen.

To begin a detailed discussion of another method of employing the system10 to fuse the sacroiliac joint, reference is made to FIGS. 112A-112D.FIG. 112A is an inferior-posterior view of the patient's hip skeletalstructure similar to the view depicted in FIG. 107A. FIG. 112B is a sideview of the patient's hip skeletal structure similar to the viewdepicted in FIG. 106A. FIG. 112C is a view of the patient's hip skeletalstructure similar to the view depicted in FIG. 103A, except from anopposite lateral perspective.

FIG. 112D is a superior view of the patient's hip skeletal structure.

As can be understood from a comparison of FIGS. 112A and 112B to FIGS.107A and 106A, respectively, in the embodiment depicted in FIGS.112A-112D, the delivery tool 20 has a trajectory that is generallysuperior-to-inferior as opposed to posterior-to-anterior. Further,unlike the embodiments described above wherein the implant 25 gainsaccess to the sacroiliac joint space 1044 via the caudal access 2016 tobe implanted in the caudal region 1086 of the sacroiliac joint space1044 (see, for example, FIG. 106B and related figures and discussion),the embodiment of FIGS. 112A-112D gains access to gains access to thesacroiliac joint space 1044 via the cranial access 2017 (e.g., at thesuperior border 3006 shown in FIG. 106B) to be implanted in the cranialregion 1087 of the sacroiliac joint space 1044 (see, for example, FIG.112C-112D).

As indicated in FIGS. 112A-112D, the delivery tool 20 is oriented suchthat the anchor collar 165 is positioned so as to deliver the anchormember 30 through the ilium 1005 first and then into the bore 40 of theimplant 25 and optionally further into the sacrum 1004. In other words,the method depicted in FIGS. 112A-112D shows the anchor member 30 beingdriven lateral to medial through the ilium 1005 first and then into theimplant followed by the sacrum 1004 (optional). Other than beingdelivered via a different trajectory and access location and beingimplanted in a different region of the sacroiliac joint, the implant 25of FIGS. 112C-112D is located in the sacroiliac joint with its wideradial members 50, narrow radial members 55 and body 45 oriented asexplained above with respect to FIGS. 102A-102D, the only differencebeing the implant 25 being accessed via, and implanted in, the cranialregion 1087 as opposed to the caudal region 1086.

To begin a detailed discussion of another method of employing the system10 to fuse the sacroiliac joint, reference is made to FIGS. 117A-117C.FIG. 117A is a lateral-inferior-posterior view of the patient's hipskeletal structure similar to the view depicted in FIG. 111C. FIG. 117Bis an inferior-posterior view of the patient's hip skeletal structuresimilar to the view depicted in FIG. 111A. FIG. 117C is the same view asFIG. 106B, except showing the implant 25 being implanted in theextra-articular space 3007, as opposed to the sacroiliac joint articularregion 1044, and accessing the extra-articular space 3007 via anextra-articular recess access region 6000. The S1 through S4 foraminacan be seen at the respective indicators S1, S2, S3 and S4 in FIGS.117A-117B.

As can be understood from a comparison of FIGS. 117A to 107A, thedelivery tool 20 has been reversed such that the anchor collar 165 isoriented so as to deliver the anchor member 30 through the sacrum 1004first and then into the bore 40 of the implant 25 and optionally furtherinto the ilium 1005. In other words, unlike the method depicted in FIG.107A, wherein the anchor member 30 is driven lateral to medial throughthe ilium 1005 first and then into the implant followed by the sacrum1004 (optional), the method depicted in FIG. 117A shows the anchormember 30 being driven medial to lateral through the sacrum 1004 firstand then into the implant followed by the ilium 1005 (optional). In theembodiment of FIG. 117A, the anchor member 30 may be a bone screw thesame as or similar to an S2 alar iliac (S2AI) screw. Such a screw maypenetrate the sacrum 1004 just lateral the lateral edge of the S1foramen and just superior the superior edge of the S1 foramen. Thus, theanchor element 30 can enter the bone of sacrum near the first sacralforamen (S2AI trajectory) then into or through implant bore 40 and canfurther enter the bone of the ilium. The implant 25, as with any of theimplantation locations and implants 25 discussed herein can optionallybe employed to be configured to serve as an attachment point forstructural components of a spinal support system with a spanning elementas discussed below with respect to FIGS. 115 and 116 or with a couplingelement as discussed below with respect to FIG. 114.

As can be understood from a comparison of FIGS. 117A to 107A, FIGS. 117Bto 111C, and FIGS. 117C to 106B, the implant 25 of FIG. 117C is locatedin the extra-articular region 3007 as opposed to the sacroiliac jointarticular region 1044. Further, the implant 25 of FIGS. 117A-C hasentered the extra-articular region 3007 via an extra-articular recessaccess region 6000, which, is on the opposite side of the posteriorinferior overhang 2020 of the posterior superior iliac spine 2004 fromthe caudal portion 1086 of the sacroiliac joint articular region 1014and posterior inferior access region 2016 leading to the sacroiliacjoint articular region 1044 employed to implant the implant 25 in thecaudal portion 1086 of the sacroiliac joint articular region 1044, asdiscussed above with respect to FIGS. 103A-108B or FIGS. 111A-111C.

As can be understood from FIG. 117C, the implant 25 is oriented in theextra-articular region 3007 with its wide radial members 50 generallycoplanar with the plane of the extra-articular region 3007 and thenarrow radial members 55 extending into the sacrum and ilium bonedefining each side of the extra-articular region 3007.

As illustrated in FIG. 117C, in some embodiments, the implant 25 isoriented within the extra-articular region 3007 such that thelongitudinal axis of the body 45 is generally perpendicular to theposterior boundary segment 3008 of the boundary 3000 of the sacroiliacjoint articular region 1014. Also, the distal end 42 of the implant 25,when implanted in the extra-articular region 3007, points towards theanterior-inferior corner 3010 of the boundary 3000 of the sacroiliacjoint articular region 1014. The distal end 42 of the implant 25 mayextend across the posterior boundary segment 3008 of the boundary 3000of the sacroiliac joint articular region 1014 and into the sacroiliacjoint articular region 1014. Thus, when implanting the implant 25 viathe extra-articular recess access region 6000, the general direction oftravel for the implant distal end 42 is towards the anterior-inferiorcorner 3010, and the implant 25 can be positioned substantially withinthe extra-articular region 3007 or, alternatively, the implant 25 can befurther advanced to also occupy a portion of the sacroiliac jointarticular region 1044.

As discussed above with respect to FIGS. 117A-117B, in implanting theimplant 25 in the extra-articular region 3007, the delivery tool 20 isconfigured to drive the anchor element 30 medial to lateral through thesacrum 1004 into the implant bore 40 and, optionally, further into theilium 1005. However, in some embodiments, the delivery tool 20 andimplant bore 40 may have as-manufactured configurations that allow theanchor element 30 to be driven lateral to medial through the ilium 1005into the implant bore 40 and, optionally, further into the sacrum 1004.

In some embodiments, the system 10 may be provided in the form of a kit4999. Such a kit 4999 is shown in FIG. 113. The kit 4999 may include thesystem 10 enclosed in a sterile main package 5000. For example, thedelivery tool 20, the implant 25 and anchor member 30 may be sealedwithin the sterile main package 5000. The delivery tool 20 may be any ofthe tool embodiments disclosed herein and may include all of itscomponents. Also, the implant 25 may be any of the implant embodimentsdisclosed herein.

As illustrated in FIG. 113, in some embodiments, the kit 4999 mayinclude multiple sizes of the implant 25 and/or multiple sizes of theanchor member 30. The multiple implants 25 may be contained in a sterileindividual package 5002 within the sterile main package 5000, and themultiple anchor members 30 may be contained in another sterileindividual package 5004 within the sterile main package 5000. Byproviding the multiple sizes of implants 25 and anchor members 30, theimplants and anchor members can be used as trials during certain stepsof the procedure to determine appropriate implant sizes and to allow aphysician, who is presented with the kit 4999 containing the deliverysystem 20 and multiple sizes of the implant and anchor members, toevaluate particular embodiments of an implant and anchor member asdescribed herein that would be best suited to a particular patient,application or implant receiving space. The kit 4999 may also oralternatively contain multiple implants 25 with different angles of bore40 to provide various desirable trajectories for an anchor member 30 andmultiple delivery systems 20 with as-manufactured angular relationscorresponding to the different angles of the bore. The kit 4999 may alsoinclude color coded, numeric or other indicators corresponding betweendelivery systems 20 and the corresponding implants 25.

In some embodiments, the kit 4999 may include instructions 5006 that layout the steps of using the system 10. The instructions 5006 may becontained within one of the sterile packages such as, for example, thesterile main package 5000. Alternatively, the instructions 5006 may beadhered or otherwise attached to an exterior surface of one of thesterile packages such as, for example, the sterile main package 5000.Alternatively, the instructions 5006 may be simply provided separatelysuch as, for example, via simply shipped loose with the rest of the kit4999, emailed, available for download at a manufacturer website, orprovided via a manufacture offered training seminar program.

In some embodiments, the kit 4999 may have any one or more of the tool20, implants 25 and anchor members 30 contained in individual sterilepackages that are not held within a sterile main package. Alternatively,the tool 20, implants 25 and anchor members 30 may be contained in asingle common package or in any combination of packages and combinationof tool, implants and anchor members.

As can be understood from FIG. 114, which is the same transverse crosssectional view of the patient's hip as shown in FIGS. 99A-99Q, once theimplant 25 and anchor(s) 30 are secured at the sacroiliac joint 1000 inany of the manners depicted in FIGS. 990-99Q, the implant 25 can be usedas an attachment point for structural components of a spinal supportsystem configured to support across the patient's hip structure and/orto support along the patient's spinal column. To serve as an attachmentpoint for structural components of a spinal support system, a couplingelement 2087 is connected to the proximal end 2011 of the sacroiliacjoint implant 25. As a non-limiting example, the coupling element 2087can be disposed in fixed relation to the proximal end 2011 of thesacroiliac joint implant 25 by threaded engagement of a fastener portion2088; however, the invention is not so limited and the fastener portion2088 can be connected to the first end 2011 of the sacroiliac jointimplant 25 by any method such as welding, spin welding, adhesive, or thelike. The coupling element 2087 can further provide a coupling portion2089 configured to join with a numerous and wide variety of crosssectional geometries of spanning members 2090. As a non-limitingexample, the coupling portion 2089 can be configured as cylindrical cup2091 pivotally coupled to the fastener portion 2088. A spiral thread canbe coupled to the internal surface of the cylindrical cup 2091 torotationally receive a spirally threaded body 2092. The side wall 2093of the cylindrical cup 2091 can include a pass through element 2094 inwhich part of a spanning member 2090 can be received. The part of thespanning member 2090 received within the pass through element 2094 canbe placed in fixed relation to the cylindrical cup 2091 by rotationalengagement of the spirally threaded body 2092.

FIG. 115 is a posterior view of the patient's sacrum 1004 and ilium1005, wherein structural components of a spinal support system extendmedial-lateral across the patient's hip structure and superiorly tosupport along the patient's spinal column. As shown in FIG. 115, in oneembodiment, each of a pair of sacroiliac joints 1000 can receive anembodiment of the sacroiliac joint implants 25, above-described, eachhaving a coupling element 2087 coupled to the first end 2011. Each ofthe coupling elements 2087 can receive the opposed ends 2095 of aspanning member 2090. Additionally, the spanning member 2090 in fixedrelation to the sacroiliac joint implants 25 can be connected to aplurality of additional spanning members 2096 which can as anon-limiting example be placed in positional relation to the vertebralcolumn 2097 to allow support of additional implants which can beanchored between vertebrae.

FIG. 116 is the same view as FIG. 117, except having a differentspanning member structure. As illustrated in FIG. 116, a first couplingelement 2087 can be joined to the first end 2011 of an embodiment of asacroiliac joint implant 25 as above described and the fastener portion2088 of a second coupling element 2087 can be disposed directly into thebone of the sacrum 1004 or the ilium 1005, or both. The opposed ends2095 of a spanning element 2090 in the form of a flat plate can provideapertures 2096 through which the fastener portion 2088 of the couplingelement 2087 can pass. The corresponding parts of the external surfaceof the coupling portion 2089 and the spanning member 2090 can be engagedto fix the location of the spanning member 2090 allowing for coupling ofthe lumbar spine to the stabilized pelvis by a plurality of fixationelements to further increase stability. As an example, fastener 2088 canbe a pedicle screw and may be implanted in the S1 pedicle and angledgenerally anteriorly and generally parallel to the S1 endplate.Additionally, spanning element 2090 can be coupled to an implant 25similar to FIGS. 41-54, or configured similarly but with the spanningelement coupled to one of the planar members (e.g., planar member 50 andwith spanning element extending radially away from the longitudinal axisof an implant 25 and at least partially existing in the plane of asacroiliac joint before contouring to the posterior surface of a sacrumand terminating at an opposed end 2095.)

As can be understood from FIG. 116 and with continuing reference toFIGS. 111A-C and 117A-C, according to particular embodiments, thespanning element 2090 can be configured to receive an S2AI screwpositioned and directed in a trajectory as substantially shown in FIG.111A-C or 117A-C. As a non-limiting example, an S2AI screw or otherelongate fixation body can pass through an aperture 2096, which can belocated on an opposed end 2095 of the spanning element 2090 and can bedisposed directly into the bone of the sacrum 1004, pass through orengage the bore 40 of an implant 25, and into the bone of the ilium1005. According to certain embodiments, an engagement between an S2AIscrew and the bore 40 can be configured, for example, as having a bore40 which can have threads or other surface that are generallycomplementary to those of a fastener 2088. Said complementary surfacescan be configured to provide a virtual cold weld between components tofurther resist undesirable movement.

As shown in FIGS. 119A-119E, which are, respectively, distal endisometric, side elevation, plan, distal end elevation, and proximal endelevation views of another embodiment of an implant 25, the features ofthe implant 25 of FIGS. 119A-119E are substantially similar to thefeatures of the implant 25 as described herein, for example with respectto FIGS. 4-17. The main differences between the implant 25 describedwith respect to FIGS. 119A-119E and the implant 25 described withrespect to FIGS. 4-17 are the lack of the cylindrical body 45 and theedges of adjacent intersecting surfaces of the implant 25 of FIGS.119A-119E are generally rounded or arcuate as opposed to sharp orwell-defined edges, as is the case between adjacent intersectingsurfaces of the implant embodiment of FIGS. 4-17. Further, the planarmembers 50 may taper distally and be relatively thicker as compared tothe planar members 55 of the implant embodiment of FIGS. 119A-119E. Forexample, the taper may extend the entire length of the implant 25 withthe thickness of planar member 50 near implant distal end 42 being about3-5 mm and the thickness of the planar member 50 near the implantproximal end 43 being about 6-7 mm. Finally, the leading or distal edges57 of the planar members 50 may be one or more tapered surfaces, asshown in FIGS. 119A-119E.

FIGS. 120A-120B are, respectively, distal end isometric and sideelevation views of yet another embodiment of the implant 25. As can beunderstood from FIGS. 120A-120B, the features of the implant 25 aresubstantially similar to the features of the implant 25 described withrespect to FIGS. 119A-119E, a main difference being that the leading ordistal edges 57 of the planar members 55 are generally sharp,well-defined angled edges, as opposed to the generally rounded orarcuate edges of the implant embodiment of FIGS. 119A-119E.

In one embodiment, as can be understood from the dashed lines in FIG.120B, the planar members 50 may be nonlinear between distal end 42 b andproximal end 43 such that there is a radius R between implant ends (orbetween distal end 42 b and a point, for example, midway along thelongitudinal axis). The radius R may be about 100 mm to about 200 mmwith one embodiment being approximately 150 mm. Accordingly, asindicated by the dashed lines in FIG. 120B, planar members 50 b mayterminate with a distal end 42 b. Additionally, but not shown in thefigures, planar members 55 may be similarly curved so as tosubstantially follow along or be aligned with curved planar members 50b. Such a configuration may more anatomically conform to the curvatureof a sacroiliac joint while allowing planar members 50 b to generallyremain within a curved plane of a sacroiliac joint.

As shown in FIGS. 121A-121E, which are, respectively, distal endisometric, side elevation, plan, distal end elevation, proximal endelevation, proximal end isometric, and side elevation views of anotherembodiment of an implant 25, the planar members 50, 55 may have surfacefeatures or texture designed to prevent migration of the implant onceimplanted in the joint space. For example, the implant 25 may includeanti-migration surface features 355, which are waved, undulating, orspiral ridges extending longitudinally along the planar members 50, 55.Alternatively, anti-migration surface features 355 may be configured toextend perpendicular to the longitudinal axis of planar members 50, 55.

It will be appreciated that the features of the implant 25 of FIGS.121A-121G are substantially as discussed herein, for example, withrespect to the implant 25 of FIGS. 62-67, a main difference being theimplant 25 is hollow and the surfaces 60 include a plurality of voids6500, which are generally triangular in shape. The voids 6500 of theimplant 25 may be filled with a biological material (e.g., a protein,demineralized bone matrix, or lattice structure containing orsubstantially comprised of stem cells) via an access opening 6502leading to the hollow interior of the implant. The biological materialis designed to improve growth of bone around the implant 25 and tostrength the integration of the implant 25 to the bone. The voids 6500improve integration of the implant 25 to the bone. Further, the leadingor distal edges 57 of the planar members 50 and the implant distal end42 of FIGS. 121A-121G may be relatively thicker as compared to theimplant embodiment of FIGS. 62-67. Additionally, as can be bestunderstood from FIG. 121C, the leading or distal edges 57 of the planarmembers 50 may differ in length and general shape. For example, as canbe understood from FIGS. 121B-121C, a first leading or distal edge 57may be generally round and arcuate and relatively longer as compared toa second leading or distal edge 57 that is generally flat and relativelyshorter. Further, as shown in FIGS. 121D, 121F and 121G, the planarmember 50 may include an access opening 6502 leading to the hollowinterior of the implant.

With an opening 6502 on one side of the implant and not on the oppositeside of the implant, the implant is configured to allow and promoteboney growth, or expansion of biological material inserted within,toward, for example, certain areas within the sacroiliac joint and awayor not toward certain other areas of the sacroiliac joint when theimplant is implanted in the sacroiliac joint. For example, when theimplant 25 of FIGS. 121A-121G is inserted into the sacroiliac jointsimilar to the manner indicated in FIG. 106B, wherein the opening 6502of the implant 25 is oriented towards the posterior boundary segment3008, boney growth or the expansion of biological material contained inthe implant will extend through the implant opening 6502 in thedirection of the posterior boundary segment 3008 and be specificallydirected away from inferior boundary 3002, anterior-inferior boundary3010 and anterior boundary segment 3004 to limit potential bone growth,or seepage of biologically active agents near the neurovascularstructures which are present beyond said boundaries.

Additionally, as can be best understood from FIGS. 121A and 121C, andwith continuing reference to FIGS. 106B and 117C, as indicated by arrowF in FIGS. 121A and 121C, one of the leading distal edges 57 (e.g., theedge located opposite the side with opening 6502) of the planar member50 of the implant may be curved and of a substantially greater radius ascompared to the distal edge 57 of the opposite planar member 50. Such acurved section (indicated by arrow F) on the distal edge 57 of planarmember 50 may be configured to anatomically generally mimic and evensubstantially conform to an anterior-inferior corner 3010 (see, e.g.,FIGS. 117C and 106B) in order to more fully occupy this region of thejoint nearest neurological and vascular structures which are presentanterior to and inferior to corner 3010.

The curved section (indicated by arrow F) (or according to particularembodiments located anywhere in implant 25) can additionally beconfigured to include an inlayed radiopaque marker, for exampletantalum, to assist the surgeon with navigation while using fluoroscopy.Further, according to particular embodiments, the curved section (arrowF) can be configured to include a stimulating electrode (NM) connectedto an internal controllable power source or external controllable powersource. For example, the external controllable power sources may beeither in the delivery system instrumentation 20 itself or a separatecontroller unit located in the operating suite and electrically coupledto the implant supported electrode NM via electrical conductorsextending through the implant body and the implant arm 110 of thedelivery system 20 to electrically couple to the separate controllerunit via a cable extending proximally from the delivery system 20 to theseparate controller. With the exception of the electrode (NM) itself,the entirety of the rest of the implant surfaces may be electricallyinsulated so as to prevent current shunting into surrounding tissues orthe operator.

In one embodiment, the stimulating electrode (NM) during navigation canhave an amperage of about 8 milliamperes (mA) or, nearing finalplacement, an amperage of about 1-4 mA and, in certain cases, up to 5mA. The electrode (NM) may be attached to or at least partially imbeddedin implant 25 (either permanently or retrievable/removable afterimplantation) (or according to particular embodiments, located within,near or on the anchor 30, probe 1054, on or within a trial, broach,drill or other tools of system 10) to reduce the risk to the patient ofiatrogenic damage to the nervous system by using intraoperativeneurophysiological monitoring, for example electromyography (EMG), whichis able to alert the surgeon or technician reliably and in real-time ofimplant 25 advancing beyond, for example, inferior boundary segment 3002or beyond anterior-inferior corner 3010.

As illustrated in FIG. 121H, which is a schematic depiction of a jointimplantation system 10 configured for nerve stimulating and sensing, inone embodiment, the system 10 includes a joint implant 25, a deliverytool 20, a nerve stimulating system 10003, a pre-amplifier unit 10004,an amplifier unit 10005, a computer 10006, and an electrical conductorpathway 10001. The joint implant 25 includes an electrode NM and a body45 including a distal end 42 and a proximal end 43 opposite the distalend. The electrode NM is supported on the implant 25. The delivery tool20 includes an implant arm 110 with a distal end 35 configured toreleasably couple to the proximal end 43 of the body 45 of the jointimplant 25. The nerve stimulating system 10003 is configured tostimulate electrode NM in order to sense nerve contact made with theelectrode NM or when NM is approaching and near a nerve. The electricalconductor pathway 10001 extends from the electrode NM along the implant25 and implant arm 110 to the nerve stimulating system 10003. Theelectrical conductor pathway 10001 places the electrode NM and nervestimulating system 10003 in electrical communication.

A sensing (or recording) electrode 10011 can be placed in, for example,a quadriceps femoris, tibialis anterior, gastrocnemius, or abductorhallucis muscle and may be coupled to an electrical conductor pathway10007 that extends to the pre-amplifier 10004. A reference electrode10010 can also be placed in, for example, a quadriceps femoris, tibialisanterior, gastrocnemius, or abductor hallucis muscle, but in a locationbetween the area subject to stimulation from the stimulating electrode(NM) and the sensing (or recording) electrode 10011; and may be coupledto an electrical conductor pathway 10012 that extends to the nervestimulating system 10003. An additional needle 10009 can be placed inproximity to the aforementioned needles (i.e., electrodes 10010, 10011)within a muscle (or when the electrode is in the form of a patch it maybe applied to the skin of the patient) and may be coupled to anelectrical conductor pathway 10008 that extends to the pre-amplifier10004 and a ground.

The pre-amplifier 10004 may be connected to the amplifier 10005 thatitself may be connected to the computer unit 10006. The computer unit10006 may process or interpret the signal from the amplifier 10005 anddisplay or otherwise alert (e.g., auditory signals with varyingamplitude or frequency) or convey to an observer or operator in anoperating suite or to a monitoring physician in a remote location (e.g.,by employing computer software and processing and networking hardware)the state of the various electrical connections and pathways (e.g.,connected versus disconnected) and electrical activity caused by thestimulating electrode NM.

In one embodiment, the proximal end 43 of the implant 25 and the distalend 35 of the implant arm include a cooperatively mating electricalconnection 10000 that form a segment of the electrical conductor pathway10001. An example of such a cooperatively mating electrical connectionincludes a male-female pin contact assembly 10000. The proximal end 80of the delivery tool 20 and a distal end of an electrical conductorsegment of the pathway 10001 between the sensing system 10003 and theproximal end 80 include a cooperatively mating electrical connection10002 that form a segment of the electrical conductor pathway 10001. Theelectrical conductor pathway 10001 may be in the form of one or moremulti-filar cables, one or more solid core wires, etc. The electrode NMis at or near the distal end 42 of the implant 25 and the rest of theimplant (or only an area directly surrounding the electrode NM) has anelectrically insulative coating or is formed of an electricallynonconductive material.

As can be understood from FIGS. 121A-121G, in one embodiment, the jointimplant 25 includes a longitudinal axis and a bore 40 extendingnon-parallel to the longitudinal axis. The joint implant 25 alsoincludes a hollow interior and an exterior surface having a plurality ofopenings 6500 defined therein that extend into the hollow interior.Prior to implantation of the implant into the joint space, the hollowinterior can be filled with a biological material via the access opening6502 that leads into the hollow interior of the implant.

The implant of FIGS. 121A-121G also includes a distal end 42, a proximalend 43, and a body extending between the proximal and distal ends. Thebore 40 extends non-parallel to the hollow interior. A first pair ofplanar members 50 radially extend from the body of the joint implant 25.Depending on the embodiment, the body may be similar to the body 45depicted in FIGS. 5-15 or the body may simply be an intersecting orintermediate region of the first pair of planar members 50, as can beunderstood from FIGS. 121A-121G.

As shown in FIGS. 121A-121G, the hollow interior extends within theconfines of the first pair of planar members 50. Also, the exteriorsurface in which the plurality of openings 6500 is defined includesexterior planar surfaces 60 of the first pair of planar members 50. Asecond pair of planar members 55 radially extend from the body of thejoint implant 25 generally perpendicular to the first pair of planarmembers 50. As can be understood from FIG. 121F, in some embodiments,the hollow interior is limited to within the confines of the first pairof planar members 50 while the second pair of planar members 55 aresolid such that the hollow interior does not enter the confines of thesecond pair of planar members. In other embodiments, the hollow interioris limited to the confines of the second pair of planar members or thehollow interior may extend into the confines of both pairs of planarmembers. As indicated in FIG. 121E, in one embodiment, the first pair ofplanar members 50 extend over a wider radial extent than the second pairof planar members 55.

FIG. 122 is a proximal end isometric view of another embodiment of theimplant assembly 15. As can be understood from FIG. 122, the features ofthe implant assembly 15 are substantially the features described herein,for example, with respect to FIG. 3, a main difference being that adistal end 6510 of the anchor element 30 includes an opening 6506 andedges 6508 in the form of serrated teeth or notches with parallel sidesinwardly terminating as an arcuate end. The opening 6508 creates agenerally “clothes-pin” like shape of the anchor element distal end6510. In one embodiment, the edges 6508 may be triangular, trapezoidal,rectangular, or another angular cross-sectional elevation and generallyevenly distributed along the surface of the anchor element distal end6510. The edges 6508 help drive the implant assembly 15 into the jointand prevent migration of the implant assembly 15 once in place.

In one embodiment, opening 6506 is defined by arms 6507. The opening6506 and arms 6507 are configured such that, after passing through achannel created in a first bone and after passing through bore 40 andthen subjected to impaction into a second bone, for example that of theilium, bone of the second bone can be received into opening 6506 to urgethe “clothes pin” arms 6507 apart from one another thereby furtherembedding the edges 6508 into bone for enhanced fixation. Alternatively,in other embodiments, anchor 30 may be configured in part or completelyof shape memory biomaterials (e.g., Nitinol or PEEK ALTERA, availablefrom MedShape, Inc. located at 1575 Northside Drive, NW, Suite 440,Atlanta, Ga. 30318 USA), which are capable of changing shape in responseto temperature, light and/or mechanical forces. An anchor 30 configuredwith a shape memory biomaterial can be configured, for example,immediately prior to insertion as substantially shown in FIG. 122 with“clothes-pins” arms 6507 in general parallel relation. Upon finalplacement in the ilium or other second bone, the “clothes-pins” arms6507 (in response to temperature, light and/or mechanical force) canseparate away from one another and in certain embodiments “curl”outwardly and back toward the proximal end of anchor 30 in order tofurther resist undesirable movement of implant assembly 15. Another maindifference between the implant assembly embodiment of FIG. 122 and ofFIG. 3 is that a washer 6504 is coupled to the anchor element 30. Thewasher 6504 and the shape and texture of the anchor member distal end6510 secure the implant assembly 15 in the sacroiliac joint. The washercan be (pivotably) coupled to the anchor such that when inserted orexplanted the washer remains coupled to the anchor and need not beremoved separately.

FIGS. 123A-123E are, respectively, distal end isometric, side elevation,plan, distal end elevation, and proximal end elevation views of yetanother embodiment of the implant 25. As can be understood from FIGS.123A-123E, many of the features of the implant 25 are substantially thefeatures of the implant 25 described herein, for example, with respectto FIGS. 119A-119E, a main difference being that the planar members 50,55 are generally round or arcuate and the implant distal end 42 isgenerally rounded. Specifically, the leading or distal edges 57 of theimplant embodiment of FIGS. 119A-119E are not separate features in theembodiment of FIGS. 123A-123E and instead are generally incorporated inthe rounded or arcuate surfaces of the planar members 50, 55, whichintersect at the implant distal tip 42. Additionally, the implantproximal end 43 is generally flat with round edges, and relatively widerthan the implant embodiment of FIGS. 119A-119E. The planar members 50may each include a channel 6514 extending longitudinally and openinginto the implant proximal end 43 adapted for receiving a distal end ofthe delivery device as described herein.

Further, another main difference is that the implant 25 shown in FIGS.123A-123E includes wings 6516, which are separated from the planarmembers 50, 55 by a gap 6512. In other words, the gap 6512 extendslongitudinally between the planar members 55 and the wings 6516 untilthe implant proximal end 43. The wings 6516 allow the implant 25 to bedriven into the joint region with the wings existing in a planetransverse to the joint plane such that one of the wings 6516 isdelivered into the sacrum and the other wing 6516 into the ilium. Thewings 6516 may include anti-migration surface features 355 in the formof notches or ribs extending inwardly in the gaps 6512 that aregenerally evenly distributed longitudinally along the wings 6516parallel to the planar members 55 and oriented transversely to thelongitudinal axis of the respective wing. The anti-migration surfacefeatures 355 and the wings 6516 prevent migration of the implant 25 onceplaced, as described herein. As can be understood from FIGS. 124E-124H,the implant of FIGS. 123A-123E may additionally include a bore 40extending through the implant 25 to receive an anchor 30 delivered viaan anchor arm 115 of the system 10 as described herein. Such a bore 40may extend through the implant so as to extend in generally the sameplane in which the wings 6516 exist.

In some embodiments, for example, the relative location and anglesbetween wings 6516 and planar members 50, 55 can remain substantiallythe same before and after implantation. Alternatively, in someembodiments, the wings 6516 can be configured to deflect a distance awayfrom planar members 50, 55 upon insertion and contact with bone. Inother words, the gaps 6512 may enlarge upon placement and, to facilitatesuch enlargement of the gaps 6512, anti-migration features 355, ordistal ends 6516A of wings 6516, may be configured with a slopingsurface to urge wings 6516 a distance away from planar members 50, 55.Upon final placement, the deflected wings 6516 urge bone or jointsurfaces against the implant 25 in order to enhance bone contact withthe implant 25 by compression to enhance bone fusion and to enhancefixation of the bones or bone fragments by potential energy stored inthe deflected wings 6516. Alternatively, according to particularembodiments, the implant 25, or only the wings 6516, may be manufacturedfrom a shape memory biomaterial. In such embodiments, the position ofthe wings 6516 before implantation may be such that their distal ends6516A are a further distance from planar members 50, 55 than shown inFIG. 123A-E. After final placement of the implant in the sacroiliacjoint, an angle 1 of the gap 6512 can decrease and the distance betweendistal ends 6516A of wings 6516 and planar members 50, 55 can decreaseby the shape memory biomaterial biasing or shaping to appearsubstantially as shown in FIGS. 123A-E. As a result, the wings 6516provide compression of the bone in gap 6512 against the surfaces of theimplant 25.

Alternatively, proximal ends 6516B of wings 6516 can be configured witha hinge between the proximal ends 6516B and the proximal end 43 ofimplant 25 to allow wings 6516 to deflect away from planar members 50,55 upon implantation. Additionally, the proximal ends 6516B can extend adistance proximally further than the proximal end 43 of implant 25.Also, an end cap can be secured to the proximal end 43 of implant 25.Advancing the end cap distally can bias the extended proximal ends 6516Baway from the longitudinal axis of implant 25 by causing rotation of thewings about the hinges. Such rotation causes the portion of the wings6516 distal said hinges to rotate an opposite complementary angulardistance toward the longitudinal axis of the implant 25, resulting incompression of bone against implant 25 for enhanced fusion and fixation.

Alternatively, proximal ends 6516B of wings 6516 may be attached toproximal end 43 of implant 25 by slidable interlocking elements. Uponimplantation the wings 6516 may be located a maximum distance away fromimplant 25 as allowed by the slidable interlocking elements and, afterfinal placement of implant 25, the wings may be drawn toward the implant25 by various methods. For example, the slidable interlocking elementsmay be configured with sloped elements which prevent movement in thedirection away from the longitudinal axis of implant 25 yet allow acompressive force, for example from a surgeon employing hemostats on thesurfaces of wings 6516 facing opposite implant 25, to irreversibly drawthe wings 6516 toward implant 25. As a second example, a gear can belocated on the proximal end 43 of implant 25, which when driven byrotational forces, by, for example, a screw driver or hex wrench, canforce wings 6516 to draw toward implant 25 while sliding along theslidable interlocking elements.

FIGS. 124A and 124B1 are isometric views of another embodiment of thedelivery tool 20 coupled and decoupled with the implant 25,respectively. FIG. 124C is an isometric view of the delivery tool 20 inan exploded state. FIG. 124D is an enlarged view of the distal end 120of the implant arm 110 of the delivery tool 20. As can be understoodfrom a comparison of FIGS. 124A-124D and FIGS. 86-88, the delivery toolembodiment of FIGS. 124A-124D is substantially similar to the deliverytool embodiment of FIGS. 86-88, a main difference being the distal end120 of the implant arm 110, as shown in FIG. 124D is adapted to engagethe channels 6514 of the implant 25 described with respect to FIGS.123A-123E. For example. The large planar members, keels, or fins 140 andthe small planar members, keels, or fins 145, as described herein, forexample, with respect to FIG. 19, may match the relative shape and sizeof the channels 6514 of the implant 25. Accordingly, the delivery toolembodiment of FIGS. 124A-124D is adapted to deliver the implant 25 intothe joint region with the wings extending in a plane that is generallytransverse to the joint plane such that each wing is received into arespective bone (e.g., sacrum or iliac) bordering the joint, asdescribed with respect to FIGS. 123A-123E.

As can be understood from FIGS. 124E and 124G, in some embodiments, theimplant has a bore 40 that has a non-circular (e.g., oblong) crosssection as taken along a cross section plane that is generallyperpendicular to the length of the bore 40 extending through theimplant. The delivery tool 20 of FIGS. 124A-D can be configured to aligna non-circular anchor 30 through the non-circular bore 40 of implant 25.For example, as shown in FIG. 124B2, a guide sleeve 100 isconcentrically contained in a collar 165 of the anchor arm 115. Thesleeve 100 has a guide hole 2444 that has a non-circular (e.g., oblong)transverse cross section that prevents rotational movement of the oblonganchor when distally displaced through the guide hole 2444. The sleeve100 may have a groove 2333 extending along a portion of its exteriorsurface length that mechanically interfaces with a complementary featuredefined in the collar, thereby preventing rotation of the sleeve withinthe collar. Since the non-circular (e.g., oblong) cross sectioned anchor30 is prevented from rotation within the complementarily shaped guidehole 2444 and the sleeve 100 is prevented from rotation within thecollar 165 due to the structural impediment presented by the groove2333, the non-circular anchor 30 can be accurately and reliablydelivered into the non-circular bore 40 of the implant 25 of FIGS. 124Eand 124G The delivery tool 20 can also be configured to be able todeliver a non-circular anchor 30 adjacent implant 25. Further, anotherdifference between the embodiment of FIGS. 124A-124D and FIGS. 86-88 isthat the anchor arm 115 as shown in FIGS. 124A-124C is contoured topermit the transverse delivery of the transfixing anchor screw 30 (e.g.,see FIG. 3) through and/or adjacent the implant 25 and across thesacroiliac joint space.

As can be understood from FIGS. 124E-124H, in one embodiment, a jointimplant 25 includes a longitudinal axis, a body 25, a distal end 42, aproximal end 43, a first wing 6516, a second wing 6516 and a bore 40extending non-parallel to the longitudinal axis. The proximal end isopposite the distal end. The first wing is connected to the body nearthe proximal end and extends distally in an offset manner from a firstlateral side of the body. The second wing is connected to the body nearthe proximal end and extends distally in an offset manner from a secondlateral side of the body opposite the first lateral side of the body.The body of the implant tapers extending proximal to distal.

As shown in FIGS. 124E-124H, the joint implant also includes a firstpair of planar members 55 radially extending from the body of the jointimplant. The first pair of planar members 55 forms at least a portion ofthe first and second lateral sides of the body from which the first andsecond wings 6514 are offset. The implant may also include a second pairof planar members 50 radially extending from the body of the jointimplant generally perpendicular to the first pair of planar members 55.The second pair of planar members may have a thickness greater than athickness of the first pair of planar members. As already stated, thefirst and second wings extend distally in an offset manner from therespective first and second lateral sides, thereby defining first andsecond respective gaps or slots 6512 between the wings and therespective lateral sides. The bore and the first and second wings residein generally the same plane.

As can be understood from FIG. 125A, which is an isometric view ofanother embodiment of the implant 25, the longitudinally extending body45 may include helical spiral threads 6524 rather than keels, fins orplanar members 50, 55 that radially extend outwardly away from the body45, as described herein. The helical spiral threads 6524 engage with thebone in the joint region to prevent migration of the implant 25.Additionally, in the embodiment shown in FIG. 125A, the body 45 isgenerally cylindrical with anti-migration surface features 355 in theform of ridges or ribs extending longitudinally along the body 45.Further, in addition to the bore 40, the body 45 may include anchormember receiving features 6520 and 6522, which are substantially similarto the bore 40, to provide a choice of a plurality of locations totransfix the anchor member 30, as described herein. Additionally, bores40 can allow bone to grow into the hollow interior of the implant asdiscussed below. For example, as shown in FIG. 125A, the body 45 mayinclude three bores, 40, 6520, and 6522 positioned relative to oneanother along the same longitudinal surface of the body 45. The implant25 may be delivered into the joint region with an embodiment of thedelivery tool 20 that includes three collars supported off of the anchorarm 115 similar to the embodiment of FIG. 110, except having at leastthree longitudinally oriented holes similar to holes 165 a and 165 b,which are at pre-set locations corresponding to the bores 40, 6520, and6522. The rest of the features shown in the implant embodiment of FIG.125A may be substantially similar to the features of implant embodimentsdescribed herein.

As shown in FIG. 125B, which is a longitudinal cross section view of theimplant 25 of FIG. 125A, the longitudinal body of implant 25 may besubstantially hollow with a distal end 42 configured with an apertureopening to the hollow interior. The hollow interior may be filled with abiological material for promoting bone growth into the hollow interior,as discussed above. Additionally, helical threads 6524 may be “T-shaped”in cross section in order to hold bone to resist a first bone frommoving relative to a second bone.

As shown in FIG. 126A, which is an isometric view of another embodimentof the implant assembly 15, the implant 25 of FIG. 126A is substantiallythe implant 25 of FIG. 125A, a main difference being that the additionalbores 6520 and 6522 are not included on the body 45. Further, featuresof the anchor element 30 are substantially similar to the features ofthe anchor element 30 described herein, for example, with respect toFIG. 3. However, the anchor element 30 as shown in FIG. 126A includeshelical spiral threads 6528 at the anchor element distal end 6529. Thehelical spiral threads 6528 of the anchor element 30 are rotationallydriven and secured into the bone. For example, the anchor elementproximal end 6531 may be adapted to engage an Allen wrench, hex key, orother tool with a hexagonal cross section to deliver the anchor element30 through the bore 40 and into the bone. Additionally, anchor 30, whenconfigured as a screw can be self-tapping.

As illustrated in FIG. 126C, which is a longitudinal cross section ofthe proximal head of the anchor 30 of FIG. 126A, in one embodiment, thehex key can be cannulated and configured to receive an anchor retainerrod with a threaded end that engages complementary threads 6537 locatedon the anchor element proximal end 6531 set below the hex key engagementcutout.

As illustrated in FIGS. 126A and 126B, the anchor 30 may have flutes6533 extending longitudinally down a portion of the shaft configured toengage a setscrew 6534, as discussed below, in order to prevent rotationof anchor 30 within the bore 40. Alternatively, anchor 30 can beconfigured with spiral flutes. Alternatively, anchor 30, whetherconfigured as a screw with threads or as a nail, may be furtherconfigured with flutes which extend circumferentially in order for asetscrew 6534, as discussed below, to engage said flutes and therebyprevent axial movement of anchor 30 within the bore 40.

As shown in FIG. 126B, which is a longitudinal cross section view of theimplant assembly 15 of FIG. 126A, the proximal end 43 of thelongitudinal body of implant 25 may be configured to receive a setscrew6534, or pair of setscrews positioned in longitudinal series in thesetscrew hole to lock the setscrews in place against each other in theset screw hole. The setscrew 6534 (or the most distal setscrew of a pairof setscrews in longitudinal series) can threadably advance distally inthe setscrew hole such that a distal end of the setscrew enters the bore40 to be received in a groove 6533 and abut against the anchor 30 toresist movement between the anchor 30 and implant 25.

As can be understood from FIGS. 125A-126B, in one embodiment, a jointimplant 25 includes a longitudinal axis, a proximal end 43, a distal end42, a body 45, a bore 40 extending non-parallel to the longitudinalaxis, and a helical thread 6524 extending around the body between theproximal and distal ends. The implant body may be substantiallycylindrical, and the bore may be a single bore 40 (see FIG. 126A) ormultiple bores 40.

As can be understood from FIGS. 127-128A, the implant arm 110 mayinclude a handle at a proximal end of the implant arm, wherein thehandle includes an elongated handle member 6532 that has a lengthperpendicular to a longitudinal axis of the implant arm. A radiopaqueelongated member 6534 extends through the elongated handle memberparallel to the length of the elongated handle member. The radiopaqueelongated member is contained in a non-radiopaque portion of theelongated handle member. As indicated in FIG. 128A, the radiopaqueelongated member may be two such members 6534, 6536 spaced apart fromeach other in the elongated handle member 6532 and residing in a planeat least parallel with, if not including, a longitudinal axis of theimplant arm 110.

As can be understood from FIGS. 126A-126B, the joint implant may alsoinclude a setscrew 6534 with a distal end that is configured to enterthe first bore 40 to abut against the anchor element 30 so as to limitmovement of the anchor element in the first bore. For example, inabutting against the anchor element, the distal end of the setscrewengages a flute 6533 defined in the anchor element.

FIG. 127 is an isometric view of an embodiment of a sleeve 6550 mountedon an implant arm 110 of a delivery device 20 similar to that of FIG.88, wherein the sleeve facilitates visualization of trans screwtrajectory. When delivering the implant 25, the arm assembly 85 isdecoupled from the implant arm 110 and the sleeve 6550 is coupled to theimplant arm 110. The handle members 6532 may be rotated to cause implantarm 110 to rotate, thereby causing the helical spiral threads 6526 tothreadably engage the bone and advancing the implant 25 into the jointregion. In one embodiment, the sleeve 6550, which may be formed of aradiotranslucent material such as PEEK or carbon fiber, includes atantalum inlay 6534 for transcrew trajectory visualization. In otherwords, the handles 6532 may include a cylindrical member 6534, which isa radiopaque marker to aid in alignment, for example, using fluoroscopywith the x-ray beam aligned generally in parallel relation to the joint.The marker 6534 runs within the handle 6532 parallel to a longitudinalcenter axis of the handle. Once the implant 25 is implanted in the jointspace as desired, the sleeve 6550 can be removed from the implant arm110 and the arm assembly 85 with its anchor arm 115 can be coupled tothe implant arm 110 in order to allow for the guided delivery of theanchor 30 into the bore 40 of the implant 25 as described herein. As canbe understood from FIG. 128A, which is an isometric view of anotherembodiment of the sleeve 6550 of FIG. 127, the features of the sleeve ofFIG. 127 are substantially the features of the sleeve embodiment of FIG.128A, a main difference being that the handle members 6532 of theembodiment of FIG. 128 include another cylindrical member 6536, whichmay be another radiopaque marker for alignment visualization. Bothmarkers 6534 and 6536 run within the handle 6532 parallel to alongitudinal center axis of the handle.

FIG. 128B is an end view of sleeve 6550 of FIG. 128A showing overlappingradiopaque markers 6534 and 6536, which are configured with terminalcircle shaped markers 6555. FIG. 128C is a posterior view of the hipregion, wherein the sleeve 6550 is being employed. As can be understoodfrom FIGS. 128A-128C, the configuration of the sleeve 6550 permits theoperator (e.g. surgeon, computer controlled navigation system, orsurgical robot) to visualize and adjust with rotational force thetrajectory, relative to anatomic structures, of an anchor 30 which canpass through a bore 40 or pass adjacent to implant 25 in order to avoidviolating neurovascular structures or other implants which may alreadybe present or are anticipated to be implanted in proximity to implantassembly 15.

As can be understood from FIGS. 128A-128C, when the implant 25 iscoupled to the implant arm 110, a longitudinal axis of the implant 25, alongitudinal axis of the bore 40, and the longitudinal axes of theradiopaque elongated members 6534, 6536 exist in a common plane. Inother words, when the implant 25 is coupled to the implant arm 110, thetwo radiopaque elongated members 6534, 6536, which are spaced apart fromeach other in the elongated handle member 6532, reside in a plane atleast parallel with, if not including, a longitudinal axis of theimplant arm 110 and/or a longitudinal axis of the bore 40. As a result,as can be understood from FIGS. 128A-128C, the radiopaque members can beused to ascertain the location and orientation of the bore when theimplant is located within the joint space, thereby helping the physicianto understand if the anchor to be delivered to or near the implant willadversely impact neurovascular structures.

Referring to FIG. 128B, it can be seen that the two radiopaque markers6534, 6536 form a single line when viewed along the plane in which bothradiopaque markers reside. This single line indicates to the physicianthe orientation of the bore 40 and a trajectory of an anchor that wouldbe received in the bore 40. Other radiopaque markers may be located onthe handle 6550 to convey other information to the physician. Forexample, additional radiopaque markers similar to markers 6534, 6536 maybe located parallel to, and offset from, markers 6534, 6536 so as toconvey to the physician a trajectory of an anchor intended to not passthrough the bore, but to instead pass adjacent to a side of the implant.

FIGS. 129A-129B show isometric views of another embodiment of the system10, wherein the delivery tool 20 has a header 6539 with a series ofcollars 165 and associated sleeves 100 having a variety of pre-definedangular alignments to guide one or more transfixing anchor members 30into place, thereby providing a choice of delivery angles that arecomplementary to the implant 25. According to particular embodiments, asleeve or collar 165 of the header 6539 depicted in FIGS. 129A-129B mayhave a longitudinal center axis LCA₁ similar to the longitudinal centeraxis LCA₁ depicted in FIG. 18, the a longitudinal center axis LCA₁ beingaligned with a trajectory which either passes into or through a bore 40of the implant 25 or passes near an implant 25 to further locate ananchor 30 into the bone of a sacrum within certain desirable areas toavoid neurovascular elements and to place the anchor within sacral bonewith a higher bone density. For example, depending on the trajectory ofthe implant 25 and the location of the bore 40 when LCA₁ is aligned withsaid bore versus placing an anchor near an implant and not through abore, an anchor can terminate generally within the sacral ala, orterminate in the body of the first sacral vertebra while avoiding thefirst sacral foramina, or terminate in a S2 vertebral body between thefirst and second sacral foramina, or terminate into the apex of thesacral promontory, or terminate through or within an anterior sacralcortex, or terminate through or near an S1 endplate.

The system 10 includes a delivery tool 20 and an implant 25 forimplanting at the sacroiliac joint via the delivery tool 20, the implant25 being for fusing the sacroiliac joint. As shown in FIGS. 129A and129B, the delivery tool 20 includes an implant arm 110 and an anchor arm115. As described herein, the implant arm 110 is configured toreleasably couple to the implant 25, and the anchor arm 115 is coupledto the implant arm 110 and configured to deliver the anchor element 30to the bore 40 of the implant 25. An impactor arm 6546 of the impactorassembly 6550 is removably coupled to handle members 6538 of the armassembly 85. Additionally, the impactor arm 6546 is removably coupled tothe implant arm 110. When the impactor assembly 6550 is coupled to thehandle members 6538 as shown in FIG. 129B, impacting an impactor handle6547 of the impactor assembly 6550 distally causes the implant arm 110,and the rest of the assembly 10 as whole, to displace distally anddeliver the implant 25 into the sacroiliac joint space. The deliverytool 20 further includes a retaining member 6548 configured to couplethe arm assembly 85 to the implant arm 110 and to engage the implant 25.The other features of the retaining member 6548 may be substantiallysimilar to the retaining member 95 as described above with respect toFIGS. 28-29. Specifically, the retainer member 6548 extends through theimplant arm 110 to mechanically interlock with a bore (e.g., center bore70) of the implant 25 as described herein. During delivery of theimplant 25, the arm assembly 85 may be decoupled from the delivery tool20 for easier delivery of the implant 25 into the joint region.Additionally, the markers 6534 and 6536 can be removable.

As discussed below in greater detail, during the implantation of theimplant assembly 15 at the sacroiliac joint, the implant 25 is supportedby the implant arm 110 and the arm assembly 85 with its collar header6539 may be coupled to the implant arm 110 to guide and support one ormore anchor elements 30 (not shown). The handle members 6538 may be usedto position or guide the implant as it is being distally driven into thesacroiliac joint via impacts delivered to the impactor handle 6547. Insome embodiments, the handle 6538 may be constructed of a radiolucentmaterial and may include radiopaque markers 6534 and 6536 similar tothose shown in FIGS. 127 and 128 for positioning the implant in theplane of the joint under fluoroscopy.

As described below, the delivery tool 20 is then used to cause the oneor more anchor elements 30 to extend through the ilium, the sacrum andthe implant 25 generally transverse to the sacroiliac joint and implant25. The delivery tool 20 is then decoupled from the implanted implantassembly 15, as described herein.

The arm assembly 85 includes the anchor arm 115 with a collar header6539 extending from the anchor arm. The collar header includes a seriesof arm members 6540, 6542, and 6544 in which a series of collars 165 aredefined at different horizontal and vertical angles. The anchor arm 115is coupled to the implant arm 110 via the handle members 6538. Dependingon the embodiment, the horizontal linear arm member 6540 may includefive collars 165 e, 165 f, 165 g, 165 h, and 165 i, each providingdifferent alignment angles, the horizontal linear arm member 6542 mayinclude two collars 165 k and 165 j, each providing different alignmentangles. The vertical arcuate arm member 6544 may include one additionalcollar 165 l plus already mentioned collar 165 f, each providingdifferent alignment angles. It will be appreciated that the collarpositions and alignments shown in the embodiment of FIGS. 129A-C are forillustrative purposes only and that other positions and alignments arecontemplated.

In one embodiment, as shown in FIGS. 124A-124C, the anchor arm 115 iscontoured having an arcuate shape. The anchor arm 115 is received in avertically extending arm member 6544 of the header 6539. The verticallyextending arm member 6544 has an arcuate configuration over its verticalextension that is generally the same as the arcuate configuration of theanchor arm 115 with respect to degree of curvature. Thus, the verticalarcuate arm member 6544 extends from the anchor arm 115 following thesame general arcuate path. The arcuate arm member 6544 may be thickerrelative to the anchor arm 115 to provide stability during the deliveryof the one or more anchor members 30 and sufficient width to accommodatethe collars 165 f and 165 l defined therein as shown in FIG. 129C. Thecollars 165 f and 165 l are defined in the generally planar surface ofthe vertical arcuate arm member 6544.

The collar header 6539 may further include horizontal linear arm members6540 and 6542, which extend perpendicularly from the vertical arcuatearm 6544. Members 6540 and 6542 may be manufactured in a fixedconfiguration or removable configuration with fixed attachment pointslocated along collar header 6539. The horizontal linear arm members 6540and 6542 have a relative thickness similar to the vertical arcuate armmember 6544 and are generally linear. The horizontal linear arm members6540 and 6542 include one or more collars 165 e-165 i and 165 k-165 jdefined on a generally planar surface of each of the horizontal lineararm members 6540 and 6542. The generally planar surfaces of thehorizontal linear arm members 6540 and 6542 intersect with the generalplanar surface of the vertical arcuate arm member 6544 to form asubstantially single generally planar surface, as shown best in FIG.129C. Accordingly, one or more of the collars 165 f may be positioned onan intersecting surface of the arcuate arm member 6544 and one of thelinear arm members 6540 or 6542.

Each of the collars 165 are configured to receive a sleeve 100 to causethe one or more anchor elements 30 to extend through the ilium, thesacrum and the implant 25 (and/or immediately adjacent to the implant)generally transverse to the sacroiliac joint and implant 25, asdescribed herein. Some collars 165, such as collars 165 f, 165 i and 165l, may be axially aligned with respective bores of the implant 25 whenthe implant 25 is supported off of the distal end of the implant arm 110of the tool 20. As a result, an anchor member 30 may be delivered intoeach of the bores via the respective anchor collars 165. Collars 165 f,165 i and 165 l are each indicated to be directed to the bore 40 by amarker 6543 showing two concentric circles. As discussed below and canbe understood from FIG. 129C, collar 165 l has a zero degree horizontaloffset by virtue of being on the vertical arm 6544, which is in parallelalignment to the plane occupied by the implant arm 110 and anchor arm115. However, collar 165 l has a 90 degree vertical offset to thelongitudinal axis of the implant arm 110 and the implant 25 mountedthereon such that a sleeve 100 extending through the collar 165 lextends in the plane occupied by the implant arm and anchor arm andfurther extends perpendicular to the longitudinal axis of the implantarm and implant. Because collar 165 l is aligned with the bore 40, theanchor delivered to the bore by the sleeve extending through collar 165l will orient the anchor in the bore in a plane occupied by the implantarm and anchor arm, but perpendicular to the longitudinal axis of theimplant. Collar 165 l may include three overlapping bores that provide a90 degree alignment angle (or slight angular variations greater than orless than 90 degrees), thereby allowing placement of an anchor 30 (ormultiple anchors in general parallel relation), for example through aslot or multiple bores 40 in implant 25, at varied distances betweenimplant ends.

As can be understood from FIG. 129C, collar 165 f has a zero degreehorizontal offset by virtue of being on the vertical arm 6544, which isin parallel alignment to the plane occupied by the implant arm 110 andanchor arm 115. However, collar 165 f has a 45 degree vertical offset tothe longitudinal axis of the implant arm 110 and the implant 25 mountedthereon such that a sleeve 100 extending through the collar 165 lextends in the plane occupied by the implant arm and anchor arm andfurther extends at a 45 degree angle to the longitudinal axis of theimplant arm and implant. Because collar 165 f is aligned with the bore40, the anchor delivered to the bore by the sleeve extending throughcollar 165 f will orient the anchor in the bore in a plane occupied bythe implant arm and anchor arm, but at 45 degrees to the longitudinalaxis of the implant.

As can be understood from FIG. 129C, collar 165 i has a 30 degreehorizontal offset by virtue of being on horizontal arm 6540 at a 30degree location. In other words, a sleeve 100 extending through collar165 i will approach the implant at an angle that is 30 degrees right ofthe plane occupied by the implant arm 110 and anchor arm 115. Further,because horizontal arm 6540 is centered horizontally on collar 165 f,which has a 45 degree vertical offset to the longitudinal axis of theimplant arm 110 and the implant 25 mounted thereon, collar 165 i willhave a 45 degree vertical offset as described with respect to collar 165f Thus, a sleeve 100 extending through collar 165 i extends at a 30degree horizontal offset angle to the plane occupied by the implant armand anchor arm and further extends at a 45 degree offset angle to thelongitudinal axis of the implant arm and implant. Because collar 165 iis aligned with the bore 40, the anchor delivered to the bore by thesleeve extending through collar 165 i will orient the anchor in the bore30 degrees offset from the plane occupied by the implant arm and anchorarm and at 45 degrees to the longitudinal axis of the implant.

The collars 165 e, 165 g, 165 h, 165 j and 165 k may be employed todeliver anchor members 30 into the bone of the ilium and sacrum whilenot passing through a bore 40 of the implant 25 (i.e., according toparticular embodiments, preconfigured to place anchor members 30immediately adjacent the longitudinal side edges of the implant 25).Such offset placement collars 165 e, 165 g, 165 h, 165 j and 165 k areeach indicated as such by a marker 6547 showing a circle tangent to arectangle, as illustrated in FIG. 129C.

As can be understood from FIG. 129C, collar 165 h has a 30 degreehorizontal offset by virtue of being on horizontal arm 6540 at a 30degree location. In other words, a sleeve 100 extending through collar165 i will approach the implant at an angle that is 30 degrees right ofthe plane occupied by the implant arm 110 and anchor arm 115 and,because the adjacent marker 6547 indicates that the anchor 30 will bedelivered adjacent to the implant 25 and not through its bore 40, theanchor will be delivered at the 30 degree angle to the left of theimplant. Further, because horizontal arm 6540 is centered horizontallyon collar 165 f, which has a 45 degree vertical offset to thelongitudinal axis of the implant arm 110 and the implant 25 mountedthereon, collar 165 h will have a 45 degree vertical offset as describedwith respect to collar 165 f. Thus, a sleeve 100 extending throughcollar 165 h extends at a 30 degree horizontal offset angle to the planeoccupied by the implant arm and anchor arm and further extends at a 45degree offset angle to the longitudinal axis of the implant arm andimplant. Because collar 165 h is not aligned with the bore 40, theanchor will be adjacent the implant (i.e., not in the bore 40). Also,the anchor 30 delivered by the sleeve extending through collar 165 hwill orient the anchor adjacent the implant 30 degrees offset from theplane occupied by the implant arm and anchor arm and at 45 degrees tothe longitudinal axis of the implant.

As can be understood from FIG. 129C, collar 165 j has a 20 degreehorizontal offset by virtue of being on horizontal arm 6542 at a 20degree location. In other words, a sleeve 100 extending through collar165 j will approach the implant at an angle that is 20 degrees right ofthe plane occupied by the implant arm 110 and anchor arm 115 and,because the adjacent marker 6547 indicates that the anchor 30 will bedelivered adjacent to the implant 25 and not through its bore 40, theanchor will be delivered at the 20 degree angle to the left of theimplant. Further, because horizontal arm 6542 is centered horizontallyat a 70 degree vertical offset to the longitudinal axis of the implantarm 110 and the implant 25 mounted thereon, collar 165 j will have a 70degree vertical offset. Thus, a sleeve 100 extending through collar 165j extends at a 20 degree horizontal offset angle to the plane occupiedby the implant arm and anchor arm and further extends at a 70 degreeoffset angle to the longitudinal axis of the implant arm and implant.Because collar 165 j is not aligned with the bore 40, the anchor will beadjacent the implant (i.e., not in the bore 40). Also, the anchor 30delivered by the sleeve extending through collar 165 j will orient theanchor adjacent the implant 20 degrees offset from the plane occupied bythe implant arm and anchor arm and at 70 degrees to the longitudinalaxis of the implant.

As can be understood from FIG. 129C, collar 165 e has a leftwardparallel offset by virtue of being on horizontal arm 6540 at a leftwardparallel offset location. In other words, a sleeve 100 extending throughcollar 165 e will approach the implant leftward offset from, andparallel to, the plane occupied by the implant arm 110 and anchor arm115 and, because the adjacent marker 6547 indicates that the anchor 30will be delivered adjacent to the implant 25 and not through its bore40, the anchor will be delivered at such a parallel arrangement and tothe left of the implant. Further, because horizontal arm 6540 iscentered horizontally on collar 165 f, which has a 45 degree verticaloffset to the longitudinal axis of the implant arm 110 and the implant25 mounted thereon, collar 165 e will have a 45 degree vertical offsetas described with respect to collar 165 f. Thus, a sleeve 100 extendingthrough collar 165 e extends at a leftward parallel offset to the planeoccupied by the implant arm and anchor arm and further extends at a 45degree offset angle to the longitudinal axis of the implant arm andimplant. Because collar 165 e is not aligned with the bore 40, theanchor will be adjacent the implant (i.e., not in the bore 40). Also,the anchor 30 delivered by the sleeve extending through collar 165 hwill orient the anchor adjacent the implant at the leftward paralleloffset from the plane occupied by the implant arm and anchor arm and at45 degrees to the longitudinal axis of the implant.

As can be understood from FIG. 129C, collar 165 k has a leftwardparallel offset by virtue of being on horizontal arm 6542 at a leftwardparallel offset location. In other words, a sleeve 100 extending throughcollar 165 k will approach the implant leftward offset from, andparallel to, the plane occupied by the implant arm 110 and anchor arm115 and, because the adjacent marker 6547 indicates that the anchor 30will be delivered adjacent to the implant 25 and not through its bore40, the anchor will be delivered at such a parallel arrangement and tothe left of the implant. Further, because horizontal arm 6542 iscentered horizontally at a 70 degree vertical offset to the longitudinalaxis of the implant arm 110 and the implant 25 mounted thereon, collar165 k will have a 70 degree vertical offset. Thus, a sleeve 100extending through collar 165 k extends at a leftward parallel offset tothe plane occupied by the implant arm and anchor arm and further extendsat a 70 degree offset angle to the longitudinal axis of the implant armand implant. Because collar 165 k is not aligned with the bore 40, theanchor will be adjacent the implant (i.e., not in the bore 40). Also,the anchor 30 delivered by the sleeve extending through collar 165 jwill orient the anchor adjacent the implant at the leftward paralleloffset from the plane occupied by the implant arm and anchor arm and at70 degrees to the longitudinal axis of the implant.

Because of the multiple collars 165, the delivery tool 20 may beadjusted to accommodate patients of different sizes and still maintainthe angular relationships between the components of system 10 thatallows one or more anchor members 30 to be delivered into a bore of theimplant 25 and/or into the bone of the ilium and sacrum immediatelyadjacent the implant, or around the implant with anchor 30 passingthrough regions 3007 or 1044, without any further adjustment to thedelivery tool 20. Because the angular relationships are rigidlymaintained between the arms 110, 115, the arm members 6540, 6542, and6544, the collars 165 of the header 6539, and the implant 25, theanchoring of the implant 25 in the sacroiliac joint via one or moreanchor members 30 may be achieved quickly and safely. In other words,because the delivery tool 20, via the multi-angle collar options of theheader 6539, provides multiple angular alignments for deploying one ormore anchor members 30 and does not need to be adjusted with respect toangular relationships, the surgery is simplified, reduced in duration,and reduces the risk of an anchor member 30 being driven through anerve, artery or vein. Additionally, collars may be color coded tocorrespond with particular implants of the same color, which indicates acomplementary configuration. Furthermore, sleeves 100 may encounterinterference elements within the collars to restrict or reduce axialmovement of the sleeve during the course of the procedure (e.g., seediscussion above with respect to FIG. 124B2).

While any one or more of the implant embodiments disclosed herein couldbe employed with the delivery device discussed with respect to FIGS.129A-129C, one version of the implant as now discussed with respect toFIGS. 129D-129L may be especially advantageous. FIGS. 129D-129K arevarious views of the implant 25, and FIG. 129L is an enlarged isometricview of the implant 25 of FIGS. 129D-129K mounted on the extreme distalend of the implant arm 110 of the delivery tool 20 of FIGS. 129A-129C.

As shown in FIGS. 129D-129K, the implant 25 includes a distal end 42 anda proximal end 43. The implant also includes a middle planar member 6579in which a central bore slot 40 is defined so as to extend through themiddle planar member 6579. The bore slot 40 may be an elongated ovalshape that has a longitudinal axis that is parallel with thelongitudinal axis of the implant 25. The elongated shape allows for ananchor 30 to be delivered through the bore slot 40 at a variety ofangles via the collars 165 f, 165 i, and 165 l discussed above withrespect to FIG. 129C.

The distal end 42 of the middle planar member 6579 has a truncated shapewith chamfered edges transition between the planar sides of the planarmember and the blunt planar distal face of the distal end of the middleplanar member. A small planar wing 6580 forms a T-shaped perpendicularintersection with a first lateral edge of the middle planar member 6579,and a large planar wing 6581 forms a T-shaped perpendicular intersectionwith a second lateral edge of the middle planar member 6579 opposite thefirst lateral edge of the middle planar member. Accordingly, as can beunderstood from FIGS. 129J and 129K, the implant has an I-shaped crosssection as viewed from either the distal or proximal ends, the largewing 6581 having a substantially larger (e.g., nearly double) width thanthe small wing 6580. Additionally, as illustrated in FIGS. 129J and129K, the implant 25 may include one or more bore shafts 10020 extendingbetween, and daylighting at, the implant distal end 42 and implantproximal end 43. Such shafts 10020 are configured to receive or passover, for example, guide pins placed in the plane of a sacroiliac joint.

As illustrated in FIG. 129D, like the distal end 42 of the middle planarmember 6579, the distal ends of the wings 6580 and 6581 also havetruncated shapes with chamfered edges transitioning between the planarsides of the wings and the blunt planar distal faces of the distal endsof the wings. While the planar surfaces of the small wing 6580 may begenerally smooth, the planar surfaces of the large wing 6581 may havelongitudinally extending evenly spaced apart grooves 6582 definedtherein. Alternatively, grooves 6582 may extend perpendicular to lengthof the implant.

As shown in FIG. 129E, the proximal end 43 of the implant 25 has agroove 6514 that extends from wing to wing across the blunt proximal end43 of the implant, the groove even extending into the outermost planarsurfaces of the wings 6580 and 6581. As can be understood from FIG.129L, when the implant 25 is mounted on the extreme distal end of theimplant arm 110, members 140 similar to those already described hereinwith respect to FIG. 124D are received in the groove 6514, and thecentral cylindrical member 220 of the retaining member 95 is received inthe proximal opening 70 to retain the implant securely on the distal endof the implant arm 110.

As indicated in FIGS. 129E and 129L, the implant 25 may have similaralignment marks 6583 that help a user to properly mount the implant onthe implant arm distal end in a correct orientation relative to eachother.

While all the various embodiments of the implant arm 110 discussed aboveare illustrated in their associated figures as having an arrangementthat results in the implant 25 being supported off of the distal end 120of the implant arm 110 such that the longitudinal axis of the implantarm is essentially axially aligned with the longitudinal axis of theimplant arm, in other embodiments, as mentioned above, the implant canbe supported off of the distal end of the implant arm in other manners.For example, as can be understood from FIG. 129M, the distal end 120 ofthe implant arm 110, which forms a distal end 35 of the overall deliverydevice 20, may be oriented so as to support the implant 25 such that thelongitudinal axis of the implant is offset from, but substantiallyparallel to the longitudinal axis of the implant arm 110. Alternatively,as can be understood from FIG. 129N, the distal end 120 of the implantarm 110 may be oriented so as to support the implant 25 such that thelongitudinal axis of the implant is substantially non-parallel to thelongitudinal axis of the implant arm 110. For example, the longitudinalaxis of the implant may form an acute angle (e.g., 45 degree) angle withthe longitudinal axis of the implant arm. Alternatively, the implant armand sleeve can be arcuate. Regardless of whether the longitudinal axisof the implant is axially aligned with, parallel with, or at an acuteangle with the longitudinal axis of the implant arm, the overalldelivery device with be so configured such that an anchor 30 can bedelivered via the implant arm 115 to a bore 40 in the implant 25 and/ora predetermined location immediately adjacent the implant without havingto adjust an angular relationship between the implant arm and the anchorarm.

As shown in FIG. 129P, the implant arm 110 of FIGS. 129M and 129N may beformed mainly of a sleeve 110Z and a retainer rod 110X. The retainer rod110X may be received coaxially within the sleeve 110Z, as illustrated inFIGS. 129M and 129N.

The retainer rod 110X includes a shaft 10030 that distally terminates inopposed arms 10032, which in turn terminate in retainer arms or prongarms 140. As shown in FIG. 129P, when the rod 110X is free of the sleeve110Z, the opposed arms 10032 are biased apart, resulting in aspace-apart distance indicated by arrow D that is sufficiently wide toallow the implant 25 to be received between the prong arms 140 at therod distal end 120.

As indicated in FIG. 129P, the sleeve 110Z includes a distal end 10040,a proximal end 10042, slots 10044 that extend into the hollow interiorof the shaft of the sleeve 110Z. The slots 10044 provide opening intothe hollow interior to facilitate sterilization of the sleeve 110Z viaan autoclave. A knurled gripping surface 10046 is defined near thesleeve proximal end 10042 so as to facilitate rotation of the sleeverelative to the rod when the threads 110Y are being threadably engaged.

As can be understood from a comparison of FIGS. 129M, 129N and 129P,when the sleeve 110Z is advanced distally over the retainer rod 110X,complementary threads 110Y on both the sleeve 110Z and retainer rod 110Xcan be engaged and the sleeve can be rotatably driven distally by saidthread engagement. The sleeve 110Z advancing distally causes prong arms140 of the retainer rod 110X to draw toward one another and in turncause the portion of the retainer rod which couples to the implant 25 tograsp said implant as can be understood from FIGS. 129L, 131G and 131H.The complementary threads when engaged may prevent proximal movement ofthe sleeve 110Z relative to the rod 110X and allow the coupling ofimplant and retainer rod to continue throughout the course of theprocedure. After implantation the sleeve 110Z may be caused to moveproximally along the retainer rod 110X in order to decouple theaforementioned tool and implant arrangement.

To illustrate the methodology associated with employing the deliverytool 20 of FIGS. 129A-129C in implanting any of the above-describedimplants 25 in the sacroiliac joint 1000 of a patient 1001, reference ismade to FIGS. 130A-130I. Specifically, FIGS. 130A-130B show anteriorviews of the hip region with the system of FIGS. 129A-129C, wherein theilium is shown and hidden, respectively. FIGS. 130C-130G showanterior-superior-lateral, posterior, superior, lateral, and inferiorviews of the hip region with the system of FIGS. 129A-129C. FIGS. 130Hand 130I show inferior and posterior-lateral views of a patient, whereinthe system of FIGS. 129A-129C is inserted through the soft tissue of thehip region. As can be understood from FIGS. 130A-130I, the curvature ofthe anchor arm 115 and the arm members 6540, 6542, and 6544 mirror theshape of the hip region 1002 to simplify surgery and increasereliability of alignment. Also, the implant 25 may be inserted into thesacroiliac joint via the implant arm 110 via the approach discussed indetail with respect to FIGS. 103A-108A, the main difference being thatthe multi-collar header 6539 facilitating the delivery of the one ormore anchors 30 into or around implant at a variety of locations andangled approaches.

A tool similar to that of FIGS. 129A-129C can be configured to beemployed for the approaches illustrated in FIGS. 111-112. For example,for an approach similar to FIG. 111, a tool similar to FIGS. 129A-129Cmay be configured without collars 165 e, 165 g-165 h, 165 j and 165 k,because these omitted collars if used for a procedure as shown in FIG.111 could undesirably direct an anchor anterior of the sacrum or iliumand outside a safe and desirable anchor trajectory. Additionally, collar165 i may be employed to direct an anchor 30 which passes through anilium and into and terminating in a bore 40 of an implant 25 as to notpass into the bone of the sacrum.

As another example, a tool similar to FIGS. 129A-129C may be configured,with 6540 and 6542 being mirrored over 6544 as to generally direct ananchor through a bore 40 of an implant 25 with a trajectory that is moreanterior to posterior or which directs an anchor generally posterior toan implant 25 when the anchor is being positioned adjacent to an implant25.

According to particular embodiments, for example, for an approachsimilar to FIG. 112, a tool similar to FIGS. 129A-129C may be configuredwithout collars 165 e, 165 g-h, 165 j and 165 k, because these omittedcollars if used for a procedure as shown in FIG. 112 could undesirablydirect an anchor inferior to the sciatic notch and outside a safe anddesirable anchor trajectory. As an example, a collar or series ofcollars could be configured to align with a bore 40 or aligned to passan anchor 30 above or superior to an adjacent implant 25 with, forexample, collars with a 45-70 degree vertical offset to the longitudinalaxis of the implant arm 110 (and the implant 25 mounted thereon), and0-45 degree horizontal offset (with 0 degrees being parallel alignmentto the plane occupied by the implant arm 110 and anchor arm 115).

As can be understood from FIGS. 131A-131B, which show isometric views ofanother embodiment of the system 10, the delivery tool 20 of FIGS.131A-131B is substantially the delivery tool of FIGS. 129A-129C, a maindifference being that the collar header 6539 does not include the secondhorizontal linear arm member 6542 extending from the vertical arcuatearm member 6544 and that the arm members 6540 and 6544 include fewercollars 165, as described below with respect to FIG. 131C. Specifically,the first horizontal linear arm member 6540 and the vertical arm 6544 ofthe embodiment of FIGS. 131A-131C include the same collar locations,angular arrangements and markers as is the case of the arms 6540 and6544 of the embodiment of FIGS. 129A-129C. FIGS. 131A-131C show theimpactor assembly 6550 decoupled from the implant arm 110 and the handlemembers 6538. However it will be understood that the impactor assembly6550 may be coupled to the implant arm 110 and the handle members 6538,as described with respect to FIGS. 129A-129C.

For a detailed discussion of the angular alignments of the collars 165,reference is made to FIG. 131C, which shows an enlarged view of the armassembly 85 with the collar header 6539. As discussed with respect toFIG. 129C, the horizontal linear arm member 6540 intersects with thevertical arcuate arm member 6544 such that one or more of the collars165 may be positioned on both the arcuate arm member 6544 and the lineararm member 6540. As shown in FIG. 131C, the arcuate arm member 6544 mayinclude two linearly aligned collars 165 p and 165 q providing differentalignment angles that are respectively the same as collars 165 f and 165l of the embodiment discussed with respect to FIG. 129C. For example,the collar 165 p may provide a 45 degree alignment angle and the collar165 q may include three overlapping bores that provide a 90 degreealignment angle. The linear arm member 6540 may include four collars 165p, 165 o, 165 n, and 165 m that are respectively the same as collars 165f, 165 g, 165 h and 165 i of the embodiment discussed with respect toFIG. 129C. For example, the collar 165 o may provide a 15 degreealignment angle and the collars 165 n and 165 m may each provide a 30degree alignment angle from different locations on the linear arm member6540. It will be appreciated that the collar positions and alignmentsshown in the embodiment of FIGS. 131A-C are for illustrative purposesonly and that other positions and alignments are contemplated.

FIGS. 131D-131E are isometric view of a version of the implant of FIGS.129D-121K adapted for use with the delivery system of FIGS. 131A-131C.As can be understood from a comparison of implant embodiment shown inFIGS. 131D-131E to the implant embodiment illustrated in FIGS.129D-129E, the main difference between the two versions of the implantis that the elongated single bore slot 40 has changed to two circularbores 40. Polyethylene bushings may define a portion of the bore holes40 of FIGS. 131D-131E.

In one embodiment, the implant 25 and a distal extension 5777 of thedistal end of the implant arm 110 can be configured to receive andremove cartilage from the sacroiliac joint. For example, as shown inFIG. 131F, which is an isometric view of a version of the implant ofFIGS. 129D-129K, the body 45 of the implant 25 is hollow along itslongitudinal length and daylights at its proximal end 43 and distal end42 in the form of proximal opening 5778 and distal opening 5779. Theside walls of the body 45 extending between the large wing 6581 andsmall wing 6580 may include openings 5780 that extend into the hollowinterior of the body 45. The openings may have a triangular or othershape.

As illustrated in FIG. 131G which is an isometric view of the distalextension 5777 of the distal end of the implant arm 110, the distalextension 5777 is a hollow rectangular box having generally smooth outerwall surfaces. As can be understood from FIG. 131H, which is anisometric view of the implant arm distal extension 5777 received in thehollow body of the implant 25, the distal extension 5777 is configuredto be received in a mating fashion that substantially matches and fillsthe hollow body of the implant 25 when the implant is supported off ofthe distal end of the implant arm 110. The matching arrangement betweenthe distal extension 5777 and the hollow interior of the body 45 of theimplant 25 is readily understandable from FIG. 131I, which is anisometric longitudinal cross section of the implant arm distal extensionand implant supported thereon as taken along section line 131I-131I ofFIG. 131H. As indicated in FIG. 131I, the interior wall surfaces of theimplant arm distal extension 5777 includes raised teeth-like ridges 5781that are oriented proximally to prevent cartilage contained in thehollow interior of the extension 5777 from distally exiting theextension 5777.

In use, the implant 25 is supported on the extension 5777 as depicted inFIGS. 131H and 131I and driven into the sacroiliac joint, therebycausing cartilage to be sliced by the leading distal rectangular edges5782 of the extension 5777 and received in the confines of the hollowinterior of the extension 5777. Once the implant 25 is positioned asdesired in the sacroiliac joint and then decoupled from the distal endof the implant arm 110, the implant arm 110 can be proximally withdrawn,thereby causing the extension 5777 to proximally exit the confines ofthe hollow interior of the implant body 45. As the extension 5777proximally withdraws, the teeth 5781 engage the cartilage located in theconfines of the hollow extension 5777, causing the cartilage to bemaintained in the confines of the hollow extension as it is proximallywithdrawn from the sacroiliac joint, thereby extracting the cartilagefrom the sacroiliac joint. The void resulting from the withdrawal of thecartilage, which happens to be the hollow interior of the implant body45, can then be filled with a metal or polymer structure to support thewalls of the implant body 45 or, alternatively, the void can be filledwith a bone growth promoting material to cause bone to infill the bodyof the implanted implant.

In one embodiment, the hollow extension 5777 is not part of the distalend of the implant arm 110, but is instead simply an insert 5777 portionof the implant 25. Thus, the insert 5777 is placed in the implant 25 andboth are then supported off of the distal end of the implant arm 110.The implant and insert 5777 are then driven into the sacroiliac joint.The implant and insert 5777 are then decoupled from the distal end ofthe implant arm 110 and left in the sacroiliac joint as the implant arm110 is proximally withdrawn from the patient. The extractor 6583described below with respect to FIGS. 134A-134E can then be employed toextract the cartilage filled insert 5777 from the confines of theimplant 25, which remains behind in the sacroiliac joint.

FIG. 132A is an isometric view of yet another embodiment of the system10 for fusing a sacroiliac joint. The system 10 includes an impactorassembly 6550, an impactor arm 110, and a retainer 6548, which issubstantially the impactor assembly, impactor arm, and retainerdescribed with respect to FIGS. 129A-129C. The system 10 furtherincludes an arm assembly 85 having handle members 6528, which havesubstantially the same features as the handle members 6538 describedwith respect to FIGS. 129A-129C, a main difference being that the handlemembers 6538 of FIGS. 132A-132B are generally cylindrical, as opposed tothe generally rectangular shape of the handle members 6538 of FIGS.129A-129C.

As shown in FIG. 132B, which is the same view as FIG. 132A, except thesystem is exploded to better illustrate its components, the anchor arm115 is contoured and curves along an arcuate path to provide axialalignment between a collar 165 and a bore or other anchor memberreceiving features on the implant 25. The collar 165 is configured toreceive a sleeve 100 to cause the one or more anchor elements 30 toextend through the ilium, the sacrum and the implant 25 generallytransverse to the sacroiliac joint and implant 25, as described herein.

The anchor arm 115 is coupled to the implant arm 110 with a lockingmember 6556. Specifically, as can be best understood from FIG. 132B, theanchor arm 115 includes an engaging member 6568 configured to slidablycouple with a channel 6566 of the implant arm 110. The couplingarrangement may be achieved via a dovetail arrangement of the channeland pins received in holes of the coupling arrangement. Once the anchorarm 115 is coupled to the implant arm 110, a distal end 6572 of thelocking member 6556 is introduced through an opening 6570 to secure theanchor arm 115 to the implant arm 110. To engage the implant 25, theretaining member 6548 is introduced through an opening 6564 in theimplant arm 110 such that a distal end 6562 of the retaining member 6548may engage the implant 25, as described herein. Finally, a distal end6558 of the impactor assembly 6550 may be introduced into an opening6560 on the implant arm 110 to couple the impactor assembly 6550 to theimplant arm 110 such that displacing the impactor assembly 6550 causesthe implant arm 110 to deliver the implant 25 to the joint region, asdescribed herein. The handles 6538 are removable from the rest of theassembly.

For a detailed discussion of yet another of the system 10 for fusing asacroiliac joint, reference is made to FIGS. 133A-133G As can beunderstood from FIGS. 133A, 133B, and 133E, an implant assembly includesthe implant arm 110, an elbow 6581, and a linear implant member 6580.The implant arm 110 has generally the same features as the implant arm110 described above and have an implant removably coupled to a distalend of the implant arm via any of the above described configurations,including a retainer member 6548 (see FIG. 132B) extending through theimplant arm. As shown in FIGS. 133A, 133B, and 133E, the implant arm 110is coupled to the linear implant member 6580 via the elbow 6581.Specifically, the linear implant member 6580 and the implant arm 110intersect at the elbow 6581 such that the implant arm 110 and the linearimplant member 6580 are positioned at an angle relative to each other.The elbow 6581 may serve as an impactor area for being impacted by animpactor in driving the implant supported on the end of the implant arminto the joint. The linear implant member 6580 is removably coupled tothe arm assembly 85 at the anchor arm 115. In other words, the linearimplant member 6580 is inserted into or otherwise couple to the anchorarm 115 and secured with the locking member 6556.

The anchor arm 115 is coupled to a linear arm member 6578, which iscoupled to an arcuate arm member 6576. In one embodiment, the linear armmember 6578 is generally parallel with the linear implant member 6580and the arcuate arm member is generally parallel with the anchor arm115. The arcuate arm member 6576 is contoured and curves along anarcuate path to provide axial alignment between collars 165 and a boreor other anchor member receiving features on the implant 25. The collars165 are each configured to receive a sleeve 100 to cause the one or moreanchor elements 30 to extend through the ilium, the sacrum and theimplant 25 generally transverse to the sacroiliac joint and implant 25,as described herein.

As indicated in FIG. 133A by dimension line R, the arcuate arm member6576 may have a curvature with a radius of between approximately 120 mmand approximately 180 mm with an arcuate length between the arrow endsof dimension line R of between approximately 200 mm and approximately400 mm. As shown in FIG. 133B, the U-shaped linear arm member 6578 ofthe anchor arm 115 extending from the proximal end of the arcuate armmember 6576 and leading to the proximal end of the implant arm 110 has adistal linear segment with a length L1 of approximately 145 mm, a middlelinear segment with a with a length L2 of between approximately 50 mmand approximately 80 mm, and a proximal linear segment with a length L3of between approximately 95 mm and approximately 145 mm.

To illustrate the methodology associated with employing the deliverytool 20 of FIGS. 133A, 133B, and 133E in implanting any of theabove-described implants 25 in the sacroiliac joint 1000 of a patient1001, reference is made to FIGS. 133C, 133D, 133F and 133G Specifically,FIGS. 133C and 133F show the same tool orientations as FIGS. 133B and133E, respectively, except the system 10 is inserted through the softtissue 1003 of the hip region 1002 of the patient 1001. FIG. 133D is thesame view as FIG. 133C, except the soft tissue is hidden to show thepatient bone structure. FIG. 133G is the same view as FIG. 133F, exceptthe soft tissue is hidden to show the patient bone structure.

As can be understood from FIGS. 133C and 133F, the curvature andrelative positions of the features of the implant assembly and the armassembly mirror the shape of the hip region 1002 to simplify surgery andincrease reliability of alignment. Further, the system 10 is relativelycompact such that it does not hinder movement during an operation. Also,the implant 25 may be inserted into the sacroiliac joint via the implantarm 110 via the approach discussed in detail with respect to FIGS.103A-108A, the main difference being that the arcuate arm member 6576 iscontoured and curves along an arcuate path to provide axial alignmentbetween multiple collars 165 and a bore or other anchor member receivingfeatures on the implant 25.

The embodiment of FIGS. 133A-133G can be used for other surgicalapproaches such as, for example, the approaches illustrated in FIGS.111A-112C. For example, for the approach shown in FIGS. 111A-111C, itmay be preferred to employ the 45 degree collar of the anchor arm 115,while for the approach depicted FIGS. 112A-112D, it may be preferred toemploy the 90 degree collar of the anchor arm 115 (i.e., the sleeve 100that is generally perpendicular to the longitudinal axis of the implantarm 110 and the implant 25 supported off of the implant arm.

The embodiment depicted in FIGS. 133A-133G offers a number ofadvantages. First, this embodiment provides more grasping area for themedical professional employing the device and allows for the hand andother body parts of the medical professional to be further from thex-ray beam of the fluoroscope. Also, the embodiment provides forincreased visualization of the surgical site by the medicalprofessional. Portions of the device, for example, 6578 are out of thearea being x-rayed for fluoro visualization, increasing thevisualization possible via fluoroscopy. Finally, clamps can be employedon the device that can be used to secure the device to a surgical tableout of the way of the x-ray beam or the imaging equipment.

For a detailed discussion of an embodiment of a system 6583 forextracting an implant, reference is made to FIGS. 134A-134E. As can beunderstood from FIG. 134A, the system 6583 includes a handle 90 and animplant retainer 95, which have features substantially similar to thehandle 90 and implant retainer 95 described herein, for example, withrespect to FIG. 3. Further, the system 6583 includes a distal end 6584having a hook 6586, which is adapted to engage with an engaging portion6588 of the implant 25.

In one embodiment, as can be understood from FIGS. 129A-129C (and in asimilar fashion from FIGS. 131A-131C, and 133A, 133B and 133E for otherembodiments), a sacroiliac joint fusion system 10 includes a jointimplant 25, an anchor element 30 and a delivery tool 20. The jointimplant includes a distal end 42 and a proximal end 43 opposite thedistal end. The anchor element comprising a distal end and a proximalend. The delivery tool includes an implant arm 110 and an anchor arm115. The implant arm includes a proximal end and a distal end. Theimplant arm distal end is configured to releasably couple to theproximal end of the joint implant. The anchor arm includes a proximalend, a distal end, a header 6539 and a member 100. The proximal end ofthe anchor arm is coupled to the implant arm, and the header issupported on the anchor arm near the distal end of the anchor arm. Theheader includes at least first and second guide holes (e.g., any two ormore of guide holes 165 e-165 l). The first guide hole (e.g., anyone ofguide holes 165 e-165 l) is configured to orient the member 100 whenreceived in the first guide hole in a first approach aimed at least inthe vicinity of the joint implant 25 when the proximal end 43 of thejoint implant is releasably coupled to the distal end of the implant arm110. Similarly, the second guide hole (e.g., any one of guide holes 165e-165 l other than the first guide hole) is configured to orient themember when received in the second guide hole in a second approach aimedat least in the vicinity of the joint implant 25 when the proximal end43 of the joint implant is releasably coupled to the distal end of theimplant arm 110. The first and second approaches are different. Themember 100 is configured to guide the delivery of the anchor element 30to at least in the vicinity of the joint implant 25 when the proximalend 43 of the joint implant is releasably coupled to the distal end ofthe implant arm 110.

Depending on the embodiment, the joint implant 25 includes a body 45extending between the distal and proximal ends 42, 43 of the jointimplant 25 and an anchor hole 40 extends through the body non-parallelto a longitudinal axis of the joint implant. The first approach is aimedso as to cause the member 100 when received in the first guide hole toguide the anchor element 30 into the anchor hole. A longitudinal axis ofthe implant arm 110 may be substantially at least one of coaxial orparallel with the longitudinal axis of the joint implant 25.

The header 6539 may include a first arm 6544 that generally exists in aplane defined by at least portions of the implant arm 110 and the anchorarm 115. The first and second guide holes 165 f, 165 l are spaced apartfrom each other along the first arm and the respective first and secondapproaches are non-parallel to each other.

The header 6539 may include a first arm 6540 or 6542 that generallyexists in a plane generally perpendicular to a plane defined by at leastportions of the implant arm 110 and the anchor arm 115. The first andsecond guide holes (e.g., any two of 165 e-165 i or 165 j-165 k,depending on which arm 6540, 6542) are spaced apart from each otheralong the first arm and the respective first and second approaches arenon-parallel to each other.

The header 6539 may include a first arm 6544 and a second arm 6540 or6542. The first arm generally exists in a first plane defined by atleast portions of the implant arm 110 and the anchor arm 115. The secondarm generally exists in a second plane generally perpendicular to thefirst plane. The first guide hole (e.g., any one of 165 f or 165 l) islocated on the first arm and the second guide hole (e.g., any one of 165e-165 i or 165 j-165 k, depending on which arm 6540, 6542) is located onthe second arm. In such an embodiment, the first and second approachesare substantially parallel to each other (e.g., where the first andsecond guide holes are 165 f and 165 e) or the first and secondapproaches are non-parallel to each other (e.g., where the first andsecond guide holes are 165 l and 165 h).

In one embodiment, as can be understood from FIGS. 129D-129K, the jointimplant 25 includes a distal end 42, a proximal end 43, and a body 6579extending between the distal and proximal ends. An anchor hole 40extends through the body non-parallel to a longitudinal axis of thejoint implant. A first planar member 6581 extends generallyperpendicular to a first lateral edge of the body 6579 of the jointimplant 25, and a second planar member 6580 extends generallyperpendicular to a second lateral edge of the body of the joint implantopposite the first lateral edge. The body 6579 is substantially a planarmember. The first planar member 6581 is larger in at least one of lengthor width than the second planar member 6580.

As can be understood from FIGS. 131F-131I, in one embodiment, the body45 may be generally hollow and include a hollow open-ended insert 5777that substantially occupies in a generally mating manner the hollowbody. The insert is removable from the body. The insert may includetextured interior wall surfaces. The interior wall surfaces define ahollow interior of the insert. The insert may be separate from thedistal end of the implant arm 110 or may be an extension of the implantarm.

As will be appreciated from FIGS. 134B-134C, which show enlarged viewsof the distal end 6584 of the system of FIG. 134A, wherein the distalend 6584 is decoupled and coupled to the implant, respectively, thehandle 90 may displace longitudinally to advance the distal end 6584towards the implant 25. As best shown in FIGS. 1328, 134C and 134D, thehook 6586 may have angular features to form a general “L-shape.” As canbe understood from FIG. 134D and FIG. 134F, which is an isometric viewof the proximal end of the implant of FIGS. 134B-134C, the proximal end43 of the implant has a central opening 70 which has an elongatedsection 70A extending radially outward from a centerline of the centralopening 70. The elongated section 70A transitions to a side opening 70Bthat is a transverse radial extension of the central opening thatdaylights at the surface of a wing portion 50 of the implant 25.

The hook 6586 may engage the implant 25 by entering the opening 70 inthe proximal end of the implant 25 such that the hook 6586 passesthrough the elongated section 70A and enters the side opening 70B toengage with an inner surface of the implant 25 in the engaging portion6588. After the hook 6586 is coupled to the engaging portion 6588, theimplant 25 may be extracted via repeatedly sliding the handle along theretainer 95 to cause the handle to repeatedly impact the cap 6599 of theretainer 95.

As can be understood from FIG. 134E, which is the same view as FIG.134A, except the system is exploded to better illustrate its components,the implant retainer 95 and the handle 90 have substantially similarfeatures to the handle 90 and the implant retainer 95 described herein,for example, with respect to FIG. 3, a main difference being that theshape of the handle 90 is contoured to fit into the palm of a user'shand and the handle is configured to slide along the retainer so as toallow impacting against the cap 6599 to create a proximally directedimpacting force that can be used to extract the implant from asacroiliac joint. The implant retainer 95 is introduced through thehandle 90, as described herein, such that a distal end 6582 of theimplant retainer 95 may be coupled with a proximal end 6590 of thedistal end 6584.

In one embodiment, as can be understood from FIGS. 134A-134E, theextractor 6583 is configured to remove a joint implant 25 including adistal end 42, a proximal end 43 opposite the distal end, a bodyextending between the distal and proximal ends, and an opening 70defined in the proximal end so as to define an inward edge 6591. Theextractor 6583 includes a distal end 6584, a proximal end 6599, a shaft95 extending between the distal and proximal ends of the extractor, anda handle 90 displaceable along the length of the shaft back and forthproximal-distal. The shaft 95 includes a distal abutment 6593 and aproximal abutment 6599 respectively near distal and proximal ends of theshaft. The handle 90 is supported on the shaft 95 between the distal andproximal abutments. The distal end 6584 of the extractor 6583 includes afeature 6586 configured to engage the inward edge 6591 when the featureis received in the opening 70. The feature may be a hook or L-shaped.

As can be understood from FIGS. 134A-134E, and with continuing referenceto FIG. 126B, in one embodiment, an anchor 40 can be configured as acable with an end that is able to be received in side opening 70B andfurther configured to allow a setscrew that may be advanced down centralopening 70 (and with abutting elements received in 70A) to abut thecable end so as to anchor the cable end within implant 25. The other endof the cable can pass through the plane of the sacroiliac joint andcommunicate with components of a pelvic or spinal fixation system.

For a discussion of an embodiment of the implant 25 that is configuredto have a shape that generally mimics and even substantially fills asacroiliac joint space, reference is made to FIGS. 135A-135C. As can beunderstood from a comparison of the side view of the implant 25 asillustrated in FIG. 135C to the shape of the sacroiliac joint articularregion 1044 depicted in FIG. 106B, the implant has an overall exteriorshape that generally mimics the sacroiliac joint articular region 1044.The anatomic implant 25 can be provided from the manufacturer in theconfiguration generally as shown in the FIGS. 135A-135C or assembled ordeployed in situ from multiple pieces, as discussed in further detailbelow. As illustrated in FIGS. 135A-135C, the implant 25 includes aproximal end 43 for being removably coupled to the extreme distal end ofan implant arm of any of the above described delivery devices 20. Theimplant proximal end 43 includes grooves 6514 and holes 75 thatinterface and couple with members 140 and 150 on the implant arm 110similar to those described above with respect to FIG. 124D and FIG. 19,respectively.

The implant 25 includes a long portion 7100 and a short portion 7101perpendicularly oriented to the long portion. The long portiontransitions smoothly into the short portion via a small radius 7102 anda large radius 7103 opposite the small radius. The large radius andsmall radius form an elbow region 7104 of the implant. The large radiusforms a heal region 7105 of the implant, and opposite the heal region isa blunt toe region 7106 forming a right angle with a base region 7107that is generally parallel to the proximal end 43. These regions7105-7107 form the distal end 42 of the implant 25.

The implant 25 can be configured similar to previously described implantembodiments wherein the body of the implant is a generally continuoussolid surface with one or more bores 40 defined therein. However, asindicated in FIGS. 135A-135C, the implant 25 may have a skeletonizedconfiguration, wherein the is an outside frame boundary 7110 thatextends unbroken and unitary through all of the above-mentioned regionsof the implant, thereby forming it outer boundary while the interior ofthe implant is generally open space across which support members 7112extend to join the outside frame boundary 7110 at different locations.As a result of its open configuration, one or more anchors 30 may beextended through the implant when implanted in the sacroiliac joint.When implanted via the approach depicted in FIGS. 103A-108B, it can beunderstood that the shape of the implant 25 of FIGS. 135A-135C may atleast somewhat resemble the sacroiliac joint space and more fully occupythe joint space than some of the more linearly shaped rectangle andcylindrical implant embodiments described above.

As can be understood from FIGS. 135A-135C, in one embodiment, asacroiliac joint fusion implant 25 includes a proximal end 43, a distalend 42 generally opposite the proximal end, and first and second lateralsides 7117, 7118 extending between the proximal and distal ends anddefining a long portion of the implant 7100 and a short portion 7107 ofthe implant. The long portion is longer than the short portion and thetwo portions extend in directions generally perpendicular to each other.The proximal end terminates proximally in a generally blunt end 7119 andthe distal end terminates distally in a generally blunt end 7106 facingin a direction generally perpendicular of the direction faced by thegenerally blunt end of the proximal end.

The generally blunt end of the proximal end is configured to releasablycouple to an implant delivery system. The region of the implant betweenthe lateral sides is open except for at least one cross member 7112extending between the lateral sides 7117, 7118. An offset distancebetween the lateral sides is substantially greater than a thickness ofthe implant. The first lateral side 7118 transitions between the longand short portions 7100, 7101 via a first curved portion 7103 and thesecond lateral side 7117 transitions between the long and short portionsvia a second curved portion 7102 having a radius smaller than the firstcurved portion. The first and second lateral sides define a shaperesembling a shape of an adult human sacroiliac joint as viewed in adirection perpendicular a plane of the sacroiliac joint. For example,the first and second lateral sides define a shape resembling a boot fora human foot.

For a discussion of an embodiment of the implant 25 that is configuredto have a shape that generally mimics and even substantially fills asacroiliac joint space after in situ deployment of certain components ofthe implant 25, reference is made to FIGS. 136A-136J. As shown in FIGS.136A-136B and 136F-1361, in one embodiment, the implant 25 includes adistal or leading end 42, a proximal or trailing end 43, alongitudinally extending body 45, a rectangular void 7540 extendingthrough the body, and keels, fins or planar members 50, 55 that radiallyextend outwardly away from the body 45. In one embodiment, the radiallyextending planar members 50, 55 may be grouped into pairs of planarmembers 50, 55 that are generally coplanar with each other. For example,planar members 50 that are opposite the body 45 from each othergenerally exist in the same plane. More specifically, as best understoodfrom FIGS. 136F and 136G, the planar faces 60 of a first planar member50 are generally coplanar with the planar faces 60 of a second planarmember 50 opposite the body 45 from the first planar member 50.Likewise, the planar faces 65 of a third planar member 55 are generallycoplanar with the planar faces 65 of a fourth planar member 55 oppositethe body 45 from the third planar member 55. The body 45 may be adistinct central portion of the implant or may simply be an intersectionof the four planar members 50, 55.

As best understood from FIGS. 136F and 136G, one set of planar members50 (i.e., the large planar members 50) may extend radially a greaterdistance than the distance extended radially by the other set of planarmembers 55 (i.e., the small planar members 55). Also, the width of alarge planar member 50 from its outer edge to its intersection with thebody 45 may be greater than the width of a small planar member 55 fromits outer edge to its intersection with the body 45. Also, the thicknessof the large planar members 50 may be greater than the thickness of thesmall planar members 55. Thus, one set of planar members 50 may be bothwider and thicker than the other set of planar members 55. In otherwords, one set of planar members 50 may be larger than the other set ofplanar members 55.

As can be understood from FIGS. 136A-136D, a toe member 7541 having asquare or rectangular boxed shape is supported in the implant body 45near the distal end 42. The toe member 7541 is moveably supported onrails 7542 relative to the rest of the implant and can be caused to moveperpendicularly to the longitudinal axis of the implant 25 from arecessed location in the implant to a position that causes the toemember 7541 to project past the extreme edge face of one of the largeplanar members 50 such that the implant changes from having arectangular box-like configuration to a boot or L-shaped configuration.

As can be understood from FIGS. 136E and 136J, the toe member 7541includes slots 7543 that matingly engage with the rails 7542 such thatthe slots can slide along the rails. A fluid conduit 7545 extends fromthe proximal end 43 to a cylinder housing 7546 in which a piston 7547 ofthe toe member is displaceably received. An O-ring 7548 seals theinterface between the cylinder inner wall and the outer circumferentialpiston surface. A pressurized fluid applied to the piston 7547 via thefluid conduit 7545 causes the toe member 7541 to move out of the rest ofthe implant so as to project laterally from the rest of the implant asindicated in FIGS. 136C-136D.

As illustrated in FIG. 136J and more clearly in FIGS. 136K and 136L,which are respective enlarged views of the upper and lower cylinderregions of FIG. 136J, a lip 10050 defined in the upper end of thecylinder housing 7546 and a lip 10051 defined in the lower end of thepiston 7547 interact to provide an extreme limit to outer movement ofthe toe member 7541. Thus, the lips act as stops to prevent the toemember from extending off of the rest of the implant due to overextension of the piston in the cylinder.

While the deployment mechanism depicted in FIGS. 136E and 136Jaccomplishes the deployment of the toe member 7541 hydraulic orpneumatic lifting mechanism, in other embodiments the deploymentmechanism may be via a screw or gear arrangement (e.g., spur, helical,rack, bevel, miter, worm, ratchet or pawl gears). Additionally, lockingmechanisms may be employed to prevent backward movement of the toemember after deployment.

As can be understood from FIGS. 136A-136J, in one embodiment, thesacroiliac joint fusion implant 25 includes a proximal end 43, a distalend 42 generally opposite the proximal end, first and second lateralsides 50, 50 extending between the proximal and distal ends, and amember 7541 near the distal end configured to displace from a firstposition to a second position. As indicated in FIGS. 136A-136B, thefirst position may be such that the member 7541 is generally recessedwithin the implant 25 such that a lateral side surface of the member isgenerally flush with the first lateral side 50. As shown in FIGS.136C-136D, the second position may be such that the member 7541 extendsfrom the first lateral side 50, the lateral side surface of the memberbeing offset from and generally parallel to the first lateral side. Themember 7541 may be displaceably supported on the implant via a railarrangement 7542, 7543. As indicated in FIGS. 136E and 136J, the implant25 may be in the form of an actuation mechanism that drives the memberfrom the first position to the second position and is actuatable via anaccess at the proximal end. For example, the actuation mechanism mayinclude a hydraulic, pneumatic, geared or screwed mechanicalarrangement.

For a discussion of an embodiment of the implant 25 that is configuredto have a shape that generally mimics and even substantially fills aportion of a sacroiliac joint space, reference is made to FIGS.137A-137F. As can be understood from a comparison of the top plan viewof the implant 25 as illustrated in FIG. 137C to the shape of thesacroiliac joint extra-articular region 3007 depicted in FIG. 106B, theimplant has an overall exterior shape that generally mimics thesacroiliac joint extra-articular region 3007. The implant has agenerally isosceles triangle shape in the top plan view. The implant 25includes a generally truncated, flat proximal end 43 from which twotapering lateral sides 8331 extend and converge at the distal end 42,which forms a rounded or arcuate distal point. A void 7540 of a shapegenerally the same as the outer shape of the implant itself is definedin the body of the implant generally centered in the implant. The topand bottom surfaces 8332 of the implant have a serrated surface withedges oriented proximally so as to prevent proximal self-migration ofthe implant once implanted in the joint. The serrated edges extendparallel to the truncated, flat proximal end 43. One or more anchors canbe extended through the void 7540 or a bone growth material can belocated in the void 7540.

FIGS. 138A-138F illustrate another embodiment the implant 25 that isconfigured to have a shape that generally mimics and even substantiallyfills a portion of a sacroiliac joint space. A comparison of theembodiment of FIGS. 138A-138F to the embodiment of FIGS. 137A-137Freveals that the embodiments are substantially similar except theembodiment of FIGS. 138A-138F has a flat, truncated distal end 42 asopposed to an arcuate end, and the void 7540 is generally a circularbore as opposed to a shape that is generally triangular like theexterior boundaries of the implant. As can be understood from FIGS. 138Cand 138D, the bore 7540 does not extend completely perpendicular betweenthe opposed top and bottom faces 7540, but instead has a slight cant ortilt.

As an example, due to idiopathic anatomic (e.g., skeletal orneurovascular) variations of certain patients it may be advantageous tohave a custom implant, anchor, alignment tool or targeting armmanufactured for a particular individual. Pre-surgical imaging studies(e.g., CT or MRI) may be performed and post-processing, including 3Drendering, may assist in planning desired anchor trajectories, anchordimensions or implant dimensions. The result of these studies and theirinterpretation may provide details specific to the manufacture ofparticular tools or implants and their implantation.

As can be understood from the foregoing, various embodiments of thedelivery tools or system configurations as described herein can besimilarly configured to operate with various embodiments of thesacroiliac joint implants disclosed in U.S. Provisional 61/520,956.

In summary and as can be understood from the preceding discussion, thesacroiliac joint fusion systems 10 disclosed herein include a jointimplant 25, an anchor element 30 and a delivery tool 20. The jointimplant 25 includes a longitudinal axis CA (e.g., see FIG. 10) and abore 40 extending non-parallel to the longitudinal axis CA. The anchorelement 30 is configured to be received in the bore 40.

The delivery tool 20 includes an implant arm 110 and an anchor arm 115.The implant arm 110 is configured to releasably couple to the jointimplant 25. The anchor arm 115 is coupled to the implant arm andconfigured to deliver the anchor element 30 to the bore 40.

The final manufactured configuration of the tool 20 and finalmanufactured configuration of the joint implant 25 are such that, whenthe system 10 is assembled such that the implant arm 110 is releasablycoupled to the joint implant 25 (e.g., as shown in FIGS. 2A, 21A, 21C,32, 37 and 109), a delivery arrangement automatically exists such thatthe anchor arm 115 is correctly oriented to deliver the anchor element30 to the bore 40. Thus, when the system 10 is shipped from themanufacturer to the medical facility where the sacroiliac joint fusionwill take place, the components 20, 25, 30, 40, 110, 115 are eachconfigured such that simply plugging them together such that the tool 20is fully assembled and the implant 25 is supported off of the distal endof the tool 20 is all that is required to employ the tool 20 to bothdeliver the implant 25 into the sacroiliac joint 1000 and deliver theanchor element 30 into the bore 40 so as to anchor the implant 25 in thesacroiliac joint. In other words, once the components of the system 10are coupled together, the cumulative result of the as-manufactured threedimensional configurations of each component of the system 10 is thatthe system 10 has a delivery arrangement such that the anchor arm 115 iscorrectly oriented to deliver the anchor element 30 to the bore 40without having to adjust the as-manufactured three dimensionalconfigurations of any of the components of the system 10. Thisautomatically arrived-at delivery arrangement is even the case whereinthe anchor arm 115 being employed is part of a plurality of anchor arms(as discussed with respect to FIG. 21B) or where the anchor arm 115 ispivotally coupled to the implant arm 110 and further equipped with anarcuate slider 105 at a free distal end of the anchor arm, the arcuateradius of the anchor arm 115 at the arcuate slider 105 being such thatthe radius extends through the bore 40 (as discussed with respect toFIG. 34).

While the implant embodiment of FIGS. 5-17 and many of the other implantembodiments described herein depict the bore 40 as being defined in theimplant body 45 such that the longitudinal axis of the bore 40 and thelongitudinal axis of the implant body 45 are coincident, in otherembodiments, the bore 40 may be defined elsewhere in the implant 25. Forexample the bore 40 may be defined in the implant body 45 such that thelongitudinal axes of the bore and implant body are offset from eachother. As another such example, the bore 40 may even be defined toextend across a wing 50, 55 so as to daylight at opposed planar surfaces60 of a large wing 50 or the opposed planar surfaces 65 of a small wing55.

Implementations of the present disclosure involve a system 10 for fusinga sacroiliac joint. The system 10 includes a delivery tool 20 and animplant assembly 15 for delivery to a sacroiliac joint via the deliverytool 20. The implant assembly 15, which includes an implant 25 and oneor more side pieces 12/14, is configured to fuse a sacroiliac joint onceimplanted at the joint. The side pieces 12/14 are integrally supportedon the implant 25 and configured to laterally project from sides of theimplant. By acting on the side pieces 12/14 or a portion of the implantat a proximal end 43 of the implant 25 (e.g., by rotational orlongitudinally displacing forces actuated by a component of the deliverytool 20 or by a separate tool 10088), the side pieces 12/14 may becaused to deploy from the sides of the implant so as to penetrate intobone material defining the joint space in which the implant 25 isimplanted. The tool 20 is configured to support the implant 25 from adistal end 35 of the delivery tool 20 for delivery of the implant intothe joint space and further configured to facilitate the deployment ofthe side pieces 12/14 from the sides of the implant. Thus, the system 10is configured such that the implant 25 can be quickly, accurately andreliably delivered to, and anchored in, a sacroiliac joint.

To begin a detailed discussion of yet other aspects and embodiments ofthe present invention, reference is made to FIGS. 139-144. FIGS. 139-140and FIG. 143 are isometric views of the implant assembly 15A. FIG. 141is an edge side elevation view of the implant assembly 15A. FIG. 142 isa lateral side plan view of the implant assembly 15A. FIG. 144 is aproximal end view of the implant assembly 15A. FIG. 145 is a distal endview of the implant assembly 15A. FIGS. 146-147 are exploded views ofthe implant assembly 15A to better illustrate its components.

As can be understood from FIGS. 139-155, the system 10A includes adelivery tool 20A and an implant assembly 15A for implanting at thesacroiliac joint via the delivery tool 20A, the implant assembly 15Abeing for fusing the sacroiliac joint. The implant assembly 15A includesa distal or leading end portion 42A, a proximal or trailing end portion43A with a longitudinal body 25A extending between the distal andproximal ends. The implant body 25A further includes first and secondside pieces or members 12A/14A, each including an opening 50A disposedtherein. The parts 6515 of distal end 35A of the delivery tool 20A mayinterface with longitudinally extending rectangular notches 6514 formedin the body 25A as discussed in the aforementioned related patentapplications and in greater detail below. In one embodiment as shown inFIGS. 144 and 145, a sacroiliac joint fusion implant 25A includes aproximal end 43A, a distal end 42A generally opposite the proximal end,and side edge surfaces 7150 extending between the proximal and distalends. An offset distance between the side edge surfaces 7150 issubstantially greater than a thickness of the implant as defined by anoffset distance between the planar lateral side surfaces 7060.

As can be understood from FIGS. 146-147, and with continuing referenceto FIGS. 139-155, the implant body 25A, includes oppositely disposedfirst and second side members 12A/14A structured and arranged to expandinto and engage the sacroiliac joint following insertion therein and anactuating body 72A. The side pieces 12A/14A are integrally supported onthe implant 25A and configured to laterally project from sides of theimplant. Side pieces 12A/14A each include a bone facing surface 7260, animplant facing surface 7261, ridges 7061, a guide mechanism for guidingthe expandable movement of the side pieces and including guide piece6606 disposed in the body portion and having, a slope 6607, and pins6601 (or as indicated in particular in FIG. 151, 6601A-D). Implant 25Amay further include slots 6600. The guide piece 6606 may be sized toallow side piece 12A/14A to be housed in implant housing 6608. Slots6600 may be configured to house pins 6601 to limit the amount oflaterally projecting movement of side pieces 12A/14A. The ridges 7061are structured and arranged to securely engage the sides of thesacroiliac joint when urged into operative engagement therewith by theactuating body 72.

To begin a detailed discussion of an implant assembly 15A in a deployedor expanded state, reference is made to FIGS. 148-154. FIGS. 148-150 areisometric views of the implant assembly 15A in a deployed or expandedstate. FIGS. 151-154 are cross section views of the implant assembly 15Ain a deployed or expanded state. As can be understood from the figures,body 72A when inserted into implant 25A via bore 70A can cause the sidepieces 12A/14A to laterally project from sides of the implant. Body 72Amay be fully or partially threaded and may have a leading end which istapered. Body 72A may be driven by longitudinally acting forces or byrotational forces by a tool 10088 through bore 70A and further driven tohit the slopes or slope surfaces 6607, thereby causing the side pieces12A/14A to laterally project from sides of the implant.

To begin a detailed discussion of a delivery tool 20A of the system 10A,reference is made to FIG. 155. In one embodiment, a delivery tool 20Afor use with the implant embodiments of the FIGS. 139-154 may beconfigured as illustrated in FIG. 155. Such a tool 20A may have animplant arm 110A formed mainly of a sleeve 110Z and a retainer rod 110X.The retainer rod 110X may be received coaxially within the sleeve 1102.

The retainer rod 110X includes a shaft 10030 that distally terminates inopposed arms 10032, which in turn terminate in retainer arms or prongarms 6515. As shown in FIG. 155, when the rod 110X is free of the sleeve110Z, the opposed arms 1032 are biased apart, resulting in a space-apartdistance indicated by arrow D that is sufficiently wide to allow theimplant 25A to be received between the prong arms 6515 at the rod distalend 120A.

As indicated in FIG. 155, the sleeve 110Z includes a distal end 10040, aproximal end 10042, slots 10044 that extend into the hollow interior ofthe shaft of the sleeve 110Z. The slots 10044 provide opening into thehollow interior to facilitate sterilization of the sleeve 110Z via anautoclave. A knurled gripping surface 10046 is defined near the sleeveproximal end 10042 so as to facilitate rotation of the sleeve relativeto the rod when the threads 110Y are being threadably engaged.

As can be understood from a comparison of FIG. 155, when the sleeve 110Zis advanced coaxially distally over the retainer rod 110X, complementarythreads 110Y on both the sleeve 110Z and retainer rod 110X can beengaged and the sleeve can be rotatably driven distally by said threadengagement. The sleeve 110Z advancing coaxially distally causes prongarms 6515 of the retainer rod 110X to draw toward one another and inturn cause the portion of the retainer rod which couples to the implant25A to grasp the implant. The complementary threads when engaged mayprevent proximal movement of the sleeve 110Z relative to the rod 110Xand allow the coupling of implant and retainer rod to continuethroughout the course of the procedure. While the tool 20A is coupled tothe implant 15A, a hex-head 10083 wrench or screwdriver 10088 with ahandle 10082 may be extended down a central lumen of the shaft 10030 toengage the hex-head end of the body 72A to drive body 72A a distancetowards implant proximal end 42A thereby causing the side pieces 12A/14Ato laterally project from sides of the implant. After implantation thesleeve 110Z may be caused to move proximally along the retainer rod 110Xin order to decouple the aforementioned tool and implant arrangement.

Referring now to FIGS. 158-164, another embodiment of an implantinsertion tool 1000A is shown. Tool 1000A is in the form of a tongapparatus and includes a handle 10004A pivotally connected at a firstend 1006A thereof to a multi-segmented elongated arm 1008A/1013A, thesegments being pivotally joined at pin 1015A. The elongated arm1008A/1013A includes a proximal end 1020A and distal end 1021A. A secondmulti-segmented elongated arm 1010A/1011A is pivotally connected at amidpoint 1012 thereof at approximately the midpoint of arm 1008A/1013Aand is operatively engaged at a proximal end 1014A thereof to a ratchet1016A positioned on handle 1004A. The segments 1010A and 1011A arepivotally connected at pin 1019A. Arm 1010A further includes a distalend 1017A oppositely disposed from distal end 1021 of arm 1008A, as ismore clearly illustrated in FIGS. 161 and 162. The arms 1018A and 1010Aare structured and arranged to form a tong-type tool adapted forinsertion of an implant into a sacroiliac joint as hereinabove describedwith respect to an alternate embodiment of this invention.

FIGS. 164-170 illustrate yet another embodiment of a sacroiliac implantdevice 3000A and insertion tool 1000B. With the exception of distal ends1017B and 1021B, insertion tool 1000B is structured in the same manneras tool 1000A described above. According, similar numerals followed bythe letter “B” are shown in the drawings to differentiate between thetwo embodiments.

As best shown in FIGS. 169 and 170, insert 3000A comprises a bodyportion 3002A having an elastic generally U-shaped middle portion 3004Aand a pair of opposite disposed legs 3006A/3008A having a proximal end3007A/3009A respectively operatively connected to the U-shaped middleportion and extending therefrom creating a spring-like force extendingtransversely therefrom. Each leg includes a generally U-shaped openingor channel 3012A/3014A formed in a distal end 3016A/3018A thereofrespectively, each channel adapted to receive a respective end1017B/1021B of tool 1000B for insertion into a joint. Each end3016A/3018A includes a plurality of outwardly extending wedge orV-shaped projections 3020A structured and arranged to be urged by thespring force of the implant into engagement with the joint interfacesinto which it is implanted.

Referring to FIGS. 171-173, yet another embodiment of a sacroiliac jointimplant is shown at 4000A. Similar in configuration and operation to theembodiment of FIGS. 169 and 170, the implant device of the instantembodiment has legs 4006A/4008A extending substantially parallel from anelastic U-shaped middle portion 4004A. Outwardly extending wedge orV-shaped projections are structured and arranged to be forcibly driveninto a joint interface upon insertion by a tool such as tool 1000Ahereinabove described.

Yet another embodiment of an implant device 5000A is depicted in FIG.174. Implant 5000A includes an expandable body portion 5002A having afirst end configured in the shape of a chisel 5004A and a second end5006A having an aperture 5008A formed therein and adapted to receive awedge element 5012A. After insertion into a sacroiliac or otherapplicable joint, wedge 5012A is forced into aperture 5008A, therebyexpanding the body portion of the implant into contact with the jointinterfaces. Four orthogonally positioned projections 5012A arestructured and arranged to be forced into engagement with the jointinterfaces, thereby securely retaining the implant in its desiredlocation.

Insertion tool 1000A further includes a pair of oppositely disposedspring elements positioned intermediate a proximate end 1020A of thefirst arm 1008A and a proximate end 1022A of the second arm 1010A tourge the proximate ends away from one another, thereby urging the distalends 1017A and 1021A into engagement with an implant 1025A. The toolfurther includes a guide member 1026A adapted to receive expandingmember 72A and tool 10088 for engagement with the expandable implantdevice for insertion and fixation in a sacroiliac joint. An x-shapedpivotal cross-brace 1028A pivotally connects at a pair of oppositelydisposed ends 1030A thereof to each of the arms 1008A and 1010A andslidably connected at a pair of second ends 1032A to the arms toreinforce and stabilize the distal end of tool 1000A during theinsertion process.

The foregoing merely illustrates the principles of the invention.Various modifications and alterations to the described embodiments willbe apparent to those skilled in the art in view of the teachings herein.It will thus be appreciated that those skilled in the art will be ableto devise numerous systems, arrangements and methods which, although notexplicitly shown or described herein, embody the principles of theinvention and are thus within the spirit and scope of the presentinvention. From the above description and drawings, it will beunderstood by those of ordinary skill in the art that the particularembodiments shown and described are for purposes of illustrations onlyand are not intended to limit the scope of the present invention.References to details of particular embodiments are not intended tolimit the scope of the invention.

To begin a detailed discussion of another method of accessing asacroiliac joint space to treat a musculoskeletal condition, referenceis made to FIGS. 175-177. To begin and as can be understood from FIGS.175 and 176, a stab incision is made in the patient's skin to create anentry point near the coccyx 1007 and the sacrotuberous ligament 1008. Acannulated blunt dissecting tool for deflecting soft tissue away fromthe sacrum 1004 may be advanced through the entry point 1009 andadvanced while following the sacrum up to a sacroiliac joint inferiorboundary 3002 which is immediately adjacent, and extends along, thesciatic notch 2024. A guide wire may then be placed through thecannulation in the dissecting tool and advanced into the sacroiliacjoint. Optionally, after the dissecting tool has been removed aninflatable bowel retractor may be advanced over the guide wire and, oncein place, inflated to provide a protected passageway 1111 for access toa sacroiliac joint. A working cannula may then be advanced over theguide wire to further protect the soft tissues from subsequent use oftools during the remainder of the procedure. The guide wire may then beremoved or alternatively left in place to be used to guide an implantdelivery tool up to the sacroiliac joint. Regardless, as can beunderstood from FIG. 177, any of the tools 20 disclosed herein can beused along the surgical pathway depicted in FIGS. 175 and 176 to delivercorresponding implant assemblies 15 into the sacroiliac joint space.

1. A method of fusing a sacroiliac joint defined between a sacrum and anilium, the method comprising: implanting a joint implant at thesacroiliac joint, the joint implant comprising a body extending a lengthbetween a proximal end and a distal end, an exterior surface, aninterior surface opposite the exterior surface and defining an internalvolume therein, a wall thickness extending between the exterior surfaceand the interior surface, a proximal opening extending into the internalvolume, and a first plurality of voids along the length and extendingthrough the wall thickness from the exterior surface to the interiorsurface, the first plurality of voids arranged along the length in arepeating pattern of a group of voids, wherein each void of the firstplurality of voids is generally polygonal in shape.
 2. The method ofclaim 1, wherein the joint implant further comprises a second pluralityof voids along the length and extending through the wall thickness fromthe exterior surface to the interior surface, and a third plurality ofvoids along the length and extending through the wall thickness from theexterior surface to the interior surface.
 3. The method of claim 2,wherein the joint implant further comprises a first leading void, and asecond leading void, the first leading void positioned distal to thefirst plurality of voids, the first leading void defining a passagewayextending through the wall thickness, and the second leading voidpositioned distal to the second plurality of voids, the second leadingvoid defining a passageway extending through the wall thickness.
 4. Themethod of claim 2, wherein each void of the first, second, and thirdplurality of voids are generally triangular in shape.
 5. The method ofclaim 1, wherein the joint implant is manufactured from titanium.
 6. Themethod of claim 1, wherein the joint implant is implantednon-transversely into the sacroiliac joint.
 7. The method of claim 1,wherein the joint implant is implanted into the sacroiliac joint suchthat portions of the joint implant extend into the ilium and the sacrum.8. The method of claim 1, further comprising packing the internal volumeat least partially with bone growth material prior to implanting thejoint implant at the sacroiliac joint.
 9. The method of claim 1, furthercomprising forming an implant receiving space in at least one of thesacrum, the ilium, or the sacroiliac joint for receiving the jointimplant prior to implanting the joint implant at the sacroiliac joint.10. The method of claim 1, wherein the group of voids comprises twovoids arranged in a mirror image of each other.
 11. A method of fusing asacroiliac joint defined between a sacrum and an ilium, the methodcomprising: implanting a joint implant at the sacroiliac joint, thejoint implant comprising a body extending a length between a proximalend and a distal end, an exterior surface having a non-circularcross-section, an interior surface opposite the exterior surface anddefining an internal volume therein, a wall thickness extending betweenthe exterior surface and the interior surface, a proximal openingextending into the internal volume, and a first plurality of voids alongthe length and extending through the wall thickness from the exteriorsurface to the interior surface, the first plurality of voids arrangedalong the length in a repeating pattern of a group of voids.
 12. Themethod of claim 11, wherein the joint implant further comprises a secondplurality of voids along the length and extending through the wallthickness from the exterior surface to the interior surface, and a thirdplurality of voids along the length and extending through the wallthickness from the exterior surface to the interior surface.
 13. Themethod of claim 12, wherein the joint implant further comprises a firstleading void, and a second leading void, the first leading voidpositioned distal to the first plurality of voids, the first leadingvoid defining a passageway extending through the wall thickness, and thesecond leading void positioned distal to the second plurality of voids,the second leading void defining a passageway extending through the wallthickness.
 14. The method of claim 12, wherein each void of the first,second, and third plurality of voids are generally triangular in shape.15. The method of claim 11, wherein the joint implant is manufacturedfrom titanium.
 16. The method of claim 11, wherein the exterior surfaceincludes a polygonal cross-section.
 17. The method of claim 16, whereinthe polygonal cross-section is rectangular.
 18. The method of claim 11,wherein the joint implant is implanted non-transversely into thesacroiliac joint.
 19. The method of claim 11, wherein the joint implantis implanted into the sacroiliac joint such that portions of the jointimplant extend into the ilium and the sacrum.
 20. The method of claim11, further comprising packing the internal volume at least partiallywith bone growth material prior to implanting the joint implant at thesacroiliac joint.
 21. The method of claim 11, further comprising formingan implant receiving space in at least one of the sacrum, the ilium, orthe sacroiliac joint for receiving the joint implant prior to implantingthe joint implant at the sacroiliac joint.
 22. The method of claim 12,wherein the group of voids comprises two voids arranged in a mirrorimage of each other.
 23. A method of fusing a sacroiliac joint definedbetween a sacrum and an ilium, the method comprising: implanting a jointimplant at the sacroiliac joint, the joint implant comprising a bodyextending a length between a proximal end and a distal end, an exteriorsurface comprising at least two generally planar side surfaces extendingat least a portion of the length, an interior surface opposite theexterior surface and defining an internal volume therein, a wallthickness extending between the exterior surface and the interiorsurface, a proximal opening extending into the internal volume, and afirst plurality of voids along the length and extending through the wallthickness from the exterior surface to the interior surface of a firstplanar side surface of the at least two generally planar side surfaces,the first plurality of voids arranged along the length of the firstplanar side surface in a repeating pattern of a group of voids.
 24. Themethod of claim 23, wherein the at least two generally planar sidesurfaces of the exterior surface define a polygonal cross-section. 25.The method of claim 24, wherein the polygonal cross-section isrectangular.
 26. The method of claim 23, wherein the joint implantfurther comprises a second plurality of voids along the length andextending through the wall thickness from the exterior surface to theinterior surface, and a third plurality of voids along the length andextending through the wall thickness from the exterior surface to theinterior surface.
 27. The method of claim 26, wherein each void of thefirst, second, and third plurality of voids are generally polygonal inshape.
 28. The method of claim 27, wherein the each void of the first,second, and third plurality of voids are generally triangular in shape.29. The method of claim 26, wherein the joint implant further comprisesa first leading void, and a second leading void, the first leading voidpositioned distal to the first plurality of voids, the first leadingvoid defining a passageway extending through the wall thickness, and thesecond leading void positioned distal to the second plurality of voids,the second leading void defining a passageway extending through the wallthickness.
 30. The method of claim 23, wherein the joint implant ismanufactured from titanium.
 31. The method of claim 23, wherein thejoint implant is implanted non-transversely into the sacroiliac joint.32. The method of claim 23, wherein the joint implant is implanted intothe sacroiliac joint such that portions of the joint implant extend intothe ilium and the sacrum.
 33. The method of claim 23, further comprisingpacking the internal volume at least partially with bone growth materialprior to implanting the joint implant at the sacroiliac joint.
 34. Themethod of claim 23, further comprising forming an implant receivingspace in at least one of the sacrum, the ilium, or the sacroiliac jointfor receiving the joint implant prior to implanting the joint implant atthe sacroiliac joint.
 35. The method of claim 23, wherein the group ofvoids comprises two voids arranged in a mirror image of each other.